Back to resultsA Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (HERIZON-GEA-01)
Primary Purpose
Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zanidatamab
Tislelizumab
Trastuzumab
Capecitabine
Oxaliplatin
Cisplatin
5-Fluorouracil
In situ hybridization (ISH)-based companion diagnostic assay
Immunohistochemistry (IHC)-based companion diagnostic assay
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Neoplasms focused on measuring HER2, Bispecific antibody, Biparatopic antibody, Immunotherapy, Gastric cancers, Esophageal cancers, Chemotherapy, FP, Capecitabine, Cisplatin, 5-FU, Oxaliplatin, Gastroesophageal adenocarcinoma, CAPOX, Programmed cell death receptor 1 (PD-1), Anti-PD-1, Anti PD-1, JZP598
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
- Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
- Adequate organ function
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)
Exclusion Criteria:
- Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Prior treatment with systemic antineoplastic therapy for unresectable locally advanced, recurrent or metastatic GEA
- Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
- Known history of or ongoing leptomeningeal disease (LMD)
- Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
- Known active hepatitis
- Any history of human immunodeficiency virus (HIV) infection
- Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
- QTc Fridericia (QTcF) > 470 ms
- Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)
Sites / Locations
- Hospital de Gastroenterología Dr Bonorino UdaondoRecruiting
- Hospital Italiano de Buenos AiresRecruiting
- Instituto de Investigaciones Metabólicas - IDIMRecruiting
- Fundación Centro de Medicina Nuclear y Molecular ERRecruiting
- Centro Médico Privado CEMAICRecruiting
- Centro de Investigación Pergamino S.A.Recruiting
- Centro de Investigaciones Médicas TucumánRecruiting
- Centro de Investigación Clínica - Clínica ViedmaRecruiting
- Border Medical Oncology Research UnitRecruiting
- Flinders Medical CentreRecruiting
- Austin HealthRecruiting
- Liverpool HospitalRecruiting
- Fiona Stanley HospitalRecruiting
- Imelda VZWRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- UZ GentRecruiting
- UZ LeuvenRecruiting
- CHU de LiègeRecruiting
- Fundação Pio XII Hospital de Câncer de BarretosRecruiting
- Hospital de Base Da Faculdade de Medicina de São José Do Rio PretoRecruiting
- Cenantron - Centro Avancado de Tratamento Oncologico LtdaRecruiting
- Hospital Amaral CarvalhoRecruiting
- Instituto Do Câncer Do Ceará ICCRecruiting
- Associação Hospital de Caridade IjuíRecruiting
- Hospital de Clinicas de Porto Alegre (HCPA) - PPDSRecruiting
- Irmandade Da Santa Casa de Misericordia de Porto AlegreRecruiting
- Hospital Sao Lucas da PUCRSRecruiting
- Hospital Nossa Senhora Da ConceiçãoRecruiting
- INCA - Instituto Nacional de Câncer José Alencar GRecruiting
- Instituto Brasileiro de Controle Do Câncer IBCCRecruiting
- Instituto de Oncologia de SorocabaRecruiting
- Instituto do Cancer do Estado de São Paulo ICESPRecruiting
- Princess Margaret Cancer CentreRecruiting
- Corporacion de Beneficencia OsornoRecruiting
- Centro de Estudios Clínicos SAGA SpARecruiting
- Research Site
- Meditek LtdaRecruiting
- Sociedad Oncovida S.ARecruiting
- IcegclinicRecruiting
- BIOCINETIC SpARecruiting
- Sociedad de Investigaciones Medicas LimitadaRecruiting
- Beijing Chao-Yang Hospital, Capital Medical University
- Cancer Hospital Chinese Academy of Medical Sciences
- Beijing Tiantan Hospital, Capital Medical University
- Beijing Cancer Hospital
- Peking University Third Hospital
- Beijing Hospital
- Peking Union Medical College Hospital
- Beijing Luhe Hospital, Capital Medical University
- The First Affiliated Hospital of Bengbu Medical College
- Research Site
- Hunan Cancer Hospital
- Changzhi People Hospital
- The First People's Hospital of Changzhou
- Sichuan Cancer Hospital & Institute
- Foshan First People's Hospital
- The First Affiliated Hospital of Fujian Medical University
- Fujian Cancer Hospital
- Guangdong Provincial People's Hospital
- The Sixth Affiliated Hospital of Sun Yat-sen University
- Hainan General Hospital
- The First Affiliated Hospital, College of Medicine, Zhejiang University
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- Second Affiliated Hospital of Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
- Harbin Medical University Cancer Hospital
- Anhui Provincial Cancer Hospital
- The Second Affiliated Hospital of Anhui Medical University
- Affiliated Hospital of Inner Mongolia Medical University
- Shandong Cancer Hospital
- Jinan Cancer Hospital
- Research Site
- Yunnan Cancer Hospital
- The First Hospital of Lanzhou University
- Gansu Provincial Cancer Hospital
- The First Affiliated Hospital of Nanchang University
- Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
- The Affiliated Hospital of Qingdao University
- Ruijin hospital Shanghai Jiao Tong University School of Medicine
- Fudan University Affiliated Zhongshan Hospital
- Shanghai 10th People's Hospital
- Shanghai East Hospital
- Research Site 1
- Research Site 2
- Shangrao People's Hospital
- The First Hospital of China Medical University
- Liaoning Cancer Hospital & Institute
- Peking University Shenzhen Hospital
- Research Site
- The Fourth Hospital of Hebei Medical University
- Tianjin Medical University General Hospital
- Tianjin Medical University Cancer Institute & Hospital
- The Tonghua Central Hospital
- Weihai Municipal Hospital
- The First Affiliated Hospital of Wenzhou Medical University
- Union Hospital Tongji Medical College HuaZhong University of Science and Technology
- Hubei Cancer Hospital
- Affiliated Hospital of Jiangnan University
- First Affiliated Hospital of Xi 'an Jiaotong University
- Research Site
- The First Affiliated Hospital of Xiamen University
- Northern Jiangsu People's Hospital
- Research Site
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- Research Site
- Cancer Hospital affiliated to Xinjiang Medical University
- Fakultni nemocnice Olomouc
- East Tallinn Central HospitalRecruiting
- North Estonia Medical Centre FoundationRecruiting
- Institut Sainte CatherineRecruiting
- Hopital Jean MinjozRecruiting
- EDOG - Institut Bergonie - PPDSRecruiting
- Universite de Bourgogne - Faculte de Medecine - INRecruiting
- Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert MichallonRecruiting
- Centre Léon BerardRecruiting
- EDOG Institut de Cancerologie de l'Ouest - PPDSRecruiting
- CHRU de Poitiers La MiletrieRecruiting
- EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDSRecruiting
- CHRU de Brest - Hopital MorvanRecruiting
- Hôpital de RangueilRecruiting
- Hôpital Saint AntoineRecruiting
- LTD TIM, Tbilisi Institute of MedicineRecruiting
- Research Institute of Clinical MedicineRecruiting
- Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical TechnologiesRecruiting
- High Technology Hospital MedCenter LtdRecruiting
- Research Site
- Medizinische Hochschule HannoverRecruiting
- Universitatsklinikum LeipzigRecruiting
- Research Site
- Universitätsklinikum UlmRecruiting
- Aretaieio Hospital of AthensRecruiting
- Attikon University General HospitalRecruiting
- Research Site
- Bioclinic Thessaloniki Oncology DepartmentRecruiting
- Agios Loucas Clinic SARecruiting
- Interbalkan Medical Center of Thessaloniki Oncology DepartmentRecruiting
- Celan S.A.Recruiting
- Integra Cancer InstituteRecruiting
- Grupo Medico AngelesRecruiting
- Centro Medico Integral de Cancerologia CEMICRecruiting
- The Bangalore HospitalRecruiting
- All India Institute of Medical Sciences, BhubaneswarRecruiting
- Artemis HospitalRecruiting
- MNJ Institute of Oncology and Regional Cancer CentreRecruiting
- Research Site
- Curie Manavata Cancer CentreRecruiting
- Indraprastha Apollo HospitalsRecruiting
- Regional Cancer Centre Indira Gandhi Institute of Medical SciencesRecruiting
- Deenanath Mangeshkar Hospital and Research CentreRecruiting
- HCG City Cancer CenterRecruiting
- St James's HospitalRecruiting
- Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola MalpighiRecruiting
- Fondazione del Piemonte per l'Oncologia (IRCCS)Recruiting
- Ospedale Policlinico San MartinoRecruiting
- Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDSRecruiting
- Ospedale San Raffaele S.r.l. - PPDSRecruiting
- Istituto Nazionale Dei TumoriRecruiting
- ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale NiguardaRecruiting
- Azienda Ospedaliero Universitaria Di Modena PoliclinicoRecruiting
- Arcispedale Santa Maria NuovaRecruiting
- Fondazione Policlinico Universitario A GemelliRecruiting
- Azienda Ospedaliera Città della Salute e della Scienza di TorinoRecruiting
- Centro Ricerche Cliniche Di VeronaRecruiting
- Azienda ULSS 8 "Berica" - Ospedale San BortoloRecruiting
- National Cancer Center Hospital EastRecruiting
- National Cancer Center HospitalRecruiting
- Shikoku Cancer CenterRecruiting
- Aichi Cancer CenterRecruiting
- The Cancer Institute Hospital of Japanese Foundation For Cancer ResearchRecruiting
- Kindai University HospitalRecruiting
- Hallym University Sacred Heart HospitalRecruiting
- Dong-A University HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- National Cancer CenterRecruiting
- Gachon University Gil Medical CenterRecruiting
- CHA Bundang Medical Center, CHA UniversityRecruiting
- Seoul National University Bundang HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- Severance Hospital Yonsei University Health System - PPDSRecruiting
- Asan Medical CenterRecruiting
- Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
- Samsung Medical CenterRecruiting
- Korea University Guro HospitalRecruiting
- Hospital Pulau PinangRecruiting
- Pantai Hospital Kuala LumpurRecruiting
- University Malaya Medical CentreRecruiting
- Sarawak General HospitalRecruiting
- National Cancer Institute ( Institut Kanser Negara)Recruiting
- Cryptex Investigación Clínica, S.A. de C.V.Recruiting
- Clinstile, S.A. de C.V.Recruiting
- Research Site 2
- Hospital Universitario Dr. Jose Eleuterio GonzálezRecruiting
- Centro de Investigacion Clinica de OaxacaRecruiting
- Catharina HospitalRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Leids Universitair Medisch CentrumRecruiting
- ETZ-ElisabethRecruiting
- Centrum Medyczne Poznan - PRATIA - PPDSRecruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziRecruiting
- Hospital Garcia de OrtaRecruiting
- Centro Hospitalar E Universitário de Coimbra EPERecruiting
- Hospital Senhora da Oliveira - Guimaraes, E.P.ERecruiting
- Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa MariaRecruiting
- Hospital Beatriz AngeloRecruiting
- Unidade Local de Saúde de Matosinhos SARecruiting
- Centro Hospitalar do Porto EPERecruiting
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDSRecruiting
- Fundeni Clinical InstituteRecruiting
- Cardiomed SRLRecruiting
- Prof Dr I Chiricuta Institute of Oncology - PPDSRecruiting
- Medisprof SRLRecruiting
- Onco Clinic Consult SARecruiting
- Oncology Center Sfantul NectarieRecruiting
- Institutul Regional de Oncologie IasiRecruiting
- Military Medical AcademyRecruiting
- University Clinical Center of Serbia - PPDSRecruiting
- Clinical Hospital Center Bezanijska KosaRecruiting
- Research Site
- University Clinical Center NisRecruiting
- Oncology Institute of VojvodinaRecruiting
- Oncocare Cancer CentreRecruiting
- Icon Cancer Centre Farrer ParkRecruiting
- Curie OncologyRecruiting
- Cape Town Oncology TrialsRecruiting
- Southern Cross Research South Africa (PTY) LTD
- University of PretoriaRecruiting
- Wilgers Oncology CentreRecruiting
- Corporacio Sanitaria Parc TauliRecruiting
- Complejo Hospitalario de NavarraRecruiting
- Hospital Universitario Germans Trias i PujolRecruiting
- Hospital Universitario Vall d'Hebron - PPDSRecruiting
- Hospital Universitari de Girona Dr Josep TruetaRecruiting
- ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La Paz - PPDSRecruiting
- Hospital Regional Universitario de Malaga - Hospital GeneralRecruiting
- Complejo Asistencial Universitario de Salamanca - H. ClinicoRecruiting
- Hospital Universitario Marques de ValdecillaRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
- Hospital Universitario Miguel ServetRecruiting
- China Medical University HospitalRecruiting
- Chi Mei Medical CenterRecruiting
- Mackay Memorial HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Siriraj Hospital Mahidol UniversityRecruiting
- Bangkok Metropolitan Administration Medical College and Vajira HospitalRecruiting
- Phramongkutklao HospitalRecruiting
- Prince of Songkla UniversityRecruiting
- Srinagarind Hospital, Khon Kaen UniversityRecruiting
- Research Site
- Chulaborn HospitalRecruiting
- Naresuan UniversityRecruiting
- Hacettepe Universitesi Kanser EnstitusuRecruiting
- Research site
- Research site
- Research site
- Research site
- Research site
- Research site
- Acibadem Maslak HospitalRecruiting
- Acibadem Adana HospitalRecruiting
- Research site
- Research site
- Research site
- Research site
- Research site
- Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
- Communal Non-profit Enterprise Regional Center of Oncology
- MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
- Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"
- Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima
- SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine
- Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center
- The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
- Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC
- Bristol Haematology and Oncology CentreRecruiting
- Western General Hospital Edinburgh - PPDSRecruiting
- St James University HospitalRecruiting
- Guy's and St Thomas' NHS Foundation Trust - Guy's HospitalRecruiting
- Royal Marsden Hospital - LondonRecruiting
- Royal Marsden Hospital - SurreyRecruiting
- Mount Vernon HospitalRecruiting
- Edith Cavell HospitalRecruiting
- Weston Park Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm C
Arm Description
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Zanidatamab plus physician's choice of CAPOX or FP
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) by blinded independent central review (BICR)
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by BICR or death from any cause
Overall survival
The time from randomization to death due to any cause
Secondary Outcome Measures
Confirmed objective response rate (ORR) by BICR
Number of patients who achieved a best overall response of complete response (CR) or (PR) as determined per RECIST 1.1 as assessed by BICR
Duration of response (DOR) by BICR
The time from the first objective response (CR or PR) per BICR to documented progressive disease per RECIST 1.1 as assessed by BICR or death from any cause
PFS per Investigator assessment
The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause
Confirmed ORR per Investigator assessment
Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator
DOR per Investigator assessment
The time from the first objective response (CR or PR) per Investigator to documented progressive disease per RECIST 1.1 as assessed by Investigator or death from any cause
Incidence of adverse events
Number of subjects who experienced adverse events or serious adverse events
Incidence of clinical laboratory abnormalities
Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30)
Changes from baseline in the EORTC QLQ-C30 scores
HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
Changes from baseline in the EORTC QLQ-OG25 scores
HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores
Serum concentration of zanidatamab and tislelizumab
Incidence of anti-drug antibodies (ADAs)
Number of patients who develop ADAs
Full Information
NCT ID
NCT05152147
First Posted
November 5, 2021
Last Updated
October 12, 2023
Sponsor
Jazz Pharmaceuticals
Collaborators
BeiGene, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05152147
Brief Title
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
Acronym
HERIZON-GEA-01
Official Title
A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
Collaborators
BeiGene, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.
The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasms, Gastroesophageal Adenocarcinoma, Esophageal Adenocarcinoma
Keywords
HER2, Bispecific antibody, Biparatopic antibody, Immunotherapy, Gastric cancers, Esophageal cancers, Chemotherapy, FP, Capecitabine, Cisplatin, 5-FU, Oxaliplatin, Gastroesophageal adenocarcinoma, CAPOX, Programmed cell death receptor 1 (PD-1), Anti-PD-1, Anti PD-1, JZP598
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multi-cohort, open-label, multicenter study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
714 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Trastuzumab (Herceptin®) plus physician's choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Zanidatamab plus physician's choice of CAPOX or FP
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Zanidatamab and tislelizumab plus physician's choice of CAPOX or FP
Intervention Type
Drug
Intervention Name(s)
Zanidatamab
Other Intervention Name(s)
ZW25, JZP598
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin®
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Administered orally (PO bid)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Intervention Description
Administered IV
Intervention Type
Diagnostic Test
Intervention Name(s)
In situ hybridization (ISH)-based companion diagnostic assay
Intervention Description
Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay
Intervention Type
Diagnostic Test
Intervention Name(s)
Immunohistochemistry (IHC)-based companion diagnostic assay
Intervention Description
Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) by blinded independent central review (BICR)
Description
The time from randomization to the date of documented disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) as assessed by BICR or death from any cause
Time Frame
Up to 2.5 years
Title
Overall survival
Description
The time from randomization to death due to any cause
Time Frame
Up to 3.5 years
Secondary Outcome Measure Information:
Title
Confirmed objective response rate (ORR) by BICR
Description
Number of patients who achieved a best overall response of complete response (CR) or (PR) as determined per RECIST 1.1 as assessed by BICR
Time Frame
Up to 2.5 years
Title
Duration of response (DOR) by BICR
Description
The time from the first objective response (CR or PR) per BICR to documented progressive disease per RECIST 1.1 as assessed by BICR or death from any cause
Time Frame
Up to 2.5 years
Title
PFS per Investigator assessment
Description
The time from randomization to the date of documented disease progression (per RECIST 1.1) as assessed by Investigator or death from any cause
Time Frame
Up to 2.5 years
Title
Confirmed ORR per Investigator assessment
Description
Number of patients who achieved a best overall response of CR or PR as determined per RECIST 1.1 as assessed by Investigator
Time Frame
Up to 2.5 years
Title
DOR per Investigator assessment
Description
The time from the first objective response (CR or PR) per Investigator to documented progressive disease per RECIST 1.1 as assessed by Investigator or death from any cause
Time Frame
Up to 2.5 years
Title
Incidence of adverse events
Description
Number of subjects who experienced adverse events or serious adverse events
Time Frame
Up to 2 years
Title
Incidence of clinical laboratory abnormalities
Description
Number of patients who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Time Frame
Up to 2 years
Title
Health-related quality of life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (core cancer questionnaire) C30 (QLQ-C30)
Description
Changes from baseline in the EORTC QLQ-C30 scores
Time Frame
Up to 2.5 years
Title
HRQoL as assessed by the EORTC Quality of Life Questionnaire (oesophago-gastric module) OG25 (QLQ-OG25)
Description
Changes from baseline in the EORTC QLQ-OG25 scores
Time Frame
Up to 2.5 years
Title
HRQoL as assessed by the EuroQol 5-dimensions 5-levels (EQ-5D-5L) questionnaire
Description
Changes from baseline in the EORTC EQ-5D-5L questionnaire scores
Time Frame
Up to 2.5 years
Title
Serum concentration of zanidatamab and tislelizumab
Time Frame
Up to 2 years
Title
Incidence of anti-drug antibodies (ADAs)
Description
Number of patients who develop ADAs
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment
Assessable (measurable or non-measurable) disease as defined by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
Adequate organ function
Left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)
Exclusion Criteria:
Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEA
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Prior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEA
Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)
Known history of or ongoing leptomeningeal disease (LMD)
Known additional malignancy that is not considered cured or that has required treatment within the past 3 years
Known active hepatitis
Any history of human immunodeficiency virus (HIV) infection
Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligible
QTc Fridericia (QTcF) > 470 ms
Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure & Transparency
Phone
215-832-3750
Email
ClinicalTrialDisclosure@JazzPharma.com
Facility Information:
Facility Name
Hospital de Gastroenterología Dr Bonorino Udaondo
City
Buenos Aires
ZIP/Postal Code
1264
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Mendez, MD
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dolores Gomez Bradley
Facility Name
Instituto de Investigaciones Metabólicas - IDIM
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1012
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martín Paskevicius, MD
Facility Name
Fundación Centro de Medicina Nuclear y Molecular ER
City
Córdoba
ZIP/Postal Code
X5000HXL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldo Riso, MD
Facility Name
Centro Médico Privado CEMAIC
City
Córdoba
ZIP/Postal Code
X5008HHW
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Salinas, MD
Facility Name
Centro de Investigación Pergamino S.A.
City
Pergamino
ZIP/Postal Code
2700
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Kahl, MD
Facility Name
Centro de Investigaciones Médicas Tucumán
City
San Miguel De Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa Susana Medina, MD
Facility Name
Centro de Investigación Clínica - Clínica Viedma
City
Viedma
ZIP/Postal Code
R8500ACE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubén Kowalyszyn, MD
Facility Name
Border Medical Oncology Research Unit
City
Albury
ZIP/Postal Code
2640
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Underhill
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amitesh Roy, MD, MSc
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niall Tebbutt, BA, BM, BCh, PhD
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weng Ng, MSc, MBBS, PhD
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Kiberu, MBChB
Facility Name
Imelda VZW
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pieter-Jan Cuyle, MD
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Van den Eynde, MD
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Geboes, MD
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Van Cutsem, MD, PhD
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joelle Collignon, MD
Facility Name
Fundação Pio XII Hospital de Câncer de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arinilda Campos Bragagnoli
Facility Name
Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathia Abdalla, MD
Facility Name
Cenantron - Centro Avancado de Tratamento Oncologico Ltda
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Murad, MD, PhD
Facility Name
Hospital Amaral Carvalho
City
Brasília
ZIP/Postal Code
70840-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Medeiros
Facility Name
Instituto Do Câncer Do Ceará ICC
City
Fortaleza
ZIP/Postal Code
60430-230
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Marcela Monteiro
Facility Name
Associação Hospital de Caridade Ijuí
City
Ijuí
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Franke, MD
Facility Name
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Perez Pereira, MD
Facility Name
Irmandade Da Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsuki Arima Tiscoski, MD
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Viola, MD
Facility Name
Hospital Nossa Senhora Da Conceição
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Janoski de Menezes, MD
Facility Name
INCA - Instituto Nacional de Câncer José Alencar G
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiano Duque, MD
Facility Name
Instituto Brasileiro de Controle Do Câncer IBCC
City
Santo André
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Jose Silva Melo Cruz, MD
Facility Name
Instituto de Oncologia de Sorocaba
City
Sorocaba
ZIP/Postal Code
18030-075
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Pires, MD, PhD
Facility Name
Instituto do Cancer do Estado de São Paulo ICESP
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila Moniz, MD
Facility Name
Princess Margaret Cancer Centre
City
Toronto
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Elimova, MD
Facility Name
Corporacion de Beneficencia Osorno
City
Osorno
ZIP/Postal Code
5290000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Hornig Epple, MD
Facility Name
Centro de Estudios Clínicos SAGA SpA
City
Providencia
ZIP/Postal Code
7500000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel Zwenger, MD
Facility Name
Research Site
City
Providencia
Country
Chile
Individual Site Status
Not yet recruiting
Facility Name
Meditek Ltda
City
Recoleta
ZIP/Postal Code
8420000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauricio Reyes, MD
Facility Name
Sociedad Oncovida S.A
City
Santiago
ZIP/Postal Code
7500000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Salman, MD
Facility Name
Icegclinic
City
Santiago
ZIP/Postal Code
8150513
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anrried Escalante, MD
Facility Name
BIOCINETIC SpA
City
Santiago
ZIP/Postal Code
8330336
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Bernaschina Olivares, MD
Facility Name
Sociedad de Investigaciones Medicas Limitada
City
Temuco
ZIP/Postal Code
4810469
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricio Yanez Weber, MD
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
101199
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
ZIP/Postal Code
233004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Changchun
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
ZIP/Postal Code
410031
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Changzhi People Hospital
City
Changzhi
ZIP/Postal Code
046099
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
ZIP/Postal Code
213004
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
ZIP/Postal Code
610042
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Foshan First People's Hospital
City
Foshan
ZIP/Postal Code
528000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
ZIP/Postal Code
510055
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
ZIP/Postal Code
510655
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hainan General Hospital
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310017
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230601
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
ZIP/Postal Code
01000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jinan Cancer Hospital
City
Jinan
ZIP/Postal Code
250013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Jining
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Yunnan Cancer Hospital
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
ZIP/Postal Code
730013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Gansu Provincial Cancer Hospital
City
Lanzhou
ZIP/Postal Code
730050
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330052
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
ZIP/Postal Code
266003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Ruijin hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fudan University Affiliated Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site 1
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site 2
City
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shangrao People's Hospital
City
Shangrao
ZIP/Postal Code
334000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
ZIP/Postal Code
110801
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518035
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Shenzhen
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
50011
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Tonghua Central Hospital
City
Tonghua
ZIP/Postal Code
143099
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Weihai Municipal Hospital
City
Weihai
ZIP/Postal Code
264200
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Union Hospital Tongji Medical College HuaZhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430023
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
ZIP/Postal Code
214062
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Xi'an
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Yangzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Research Site
City
Zhengzhou
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Cancer Hospital affiliated to Xinjiang Medical University
City
Ürümqi
ZIP/Postal Code
830026
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Esko, MD
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niina Kippasto, MD
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clémence Toullec, MD
Facility Name
Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Borg, MD, PhD
Facility Name
EDOG - Institut Bergonie - PPDS
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Pernot, MD
Facility Name
Universite de Bourgogne - Faculte de Medecine - IN
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Ghiringhelli, MD
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gael Roth, MD
Facility Name
Centre Léon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle De La Fouchardière, MD
Facility Name
EDOG Institut de Cancerologie de l'Ouest - PPDS
City
Nantes
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Raimbourg, MD
Facility Name
CHRU de Poitiers La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tougeron, MD
Facility Name
EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS
City
Rennes
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Le Sourd, MD
Facility Name
CHRU de Brest - Hopital Morvan
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Metges, MD
Facility Name
Hôpital de Rangueil
City
Toulouse
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosine Guimbaud
Facility Name
Hôpital Saint Antoine
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Cohen, MD
Facility Name
LTD TIM, Tbilisi Institute of Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Gogishvili, MD
Facility Name
Research Institute of Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Melkadze, MD
Facility Name
Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Gogishvili, MD
Facility Name
High Technology Hospital MedCenter Ltd
City
Tbilisi
ZIP/Postal Code
6000
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamta Makharadze, MD
Facility Name
Research Site
City
Frankfurt am Main
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arndt Vogel, MD
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Lordick, MD
Facility Name
Research Site
City
Trier
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Ettrich, MD
Facility Name
Aretaieio Hospital of Athens
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christos Papadimitriou, MD
Facility Name
Attikon University General Hospital
City
Athens
ZIP/Postal Code
124 64
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Psyrri, MD
Facility Name
Research Site
City
Piraeus
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Bioclinic Thessaloniki Oncology Department
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioannis Boukovinas, MD, PhD, PharmD
Facility Name
Agios Loucas Clinic SA
City
Thessaloniki
ZIP/Postal Code
552 36
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ippokratis Korantzis
Facility Name
Interbalkan Medical Center of Thessaloniki Oncology Department
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Baka, MD
Facility Name
Celan S.A.
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agatha Mireya Reyes Morales, MD
Facility Name
Integra Cancer Institute
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pier Anyelo Ramos Elías, MD
Facility Name
Grupo Medico Angeles
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Castro, MD
Facility Name
Centro Medico Integral de Cancerologia CEMIC
City
Salcaja
ZIP/Postal Code
09002
Country
Guatemala
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Chivalan, MD
Facility Name
The Bangalore Hospital
City
Bangalore
ZIP/Postal Code
560068
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajeev Krishnappa, MD
Facility Name
All India Institute of Medical Sciences, Bhubaneswar
City
Bhubaneswar
ZIP/Postal Code
751019
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saroj Das Majumdar, MD
Facility Name
Artemis Hospital
City
Gurgaon
ZIP/Postal Code
122003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vineet Gupta, MD
Facility Name
MNJ Institute of Oncology and Regional Cancer Centre
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srinivasulu Mukta, MD
Facility Name
Research Site
City
Jaipur
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Curie Manavata Cancer Centre
City
Nashik
ZIP/Postal Code
422002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajnish Nagarkar, MD
Facility Name
Indraprastha Apollo Hospitals
City
New Delhi
ZIP/Postal Code
110076
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Singhal, DM, MD
Facility Name
Regional Cancer Centre Indira Gandhi Institute of Medical Sciences
City
Patna
ZIP/Postal Code
800014
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajesh Kumar Singh
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
ZIP/Postal Code
411006
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chetan Deshmukh, DM, DMD, DN, MBBS, MD
Facility Name
HCG City Cancer Center
City
Vijayawada
ZIP/Postal Code
520002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gopichand Mamillapalli, MD
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maeve Lowery
Facility Name
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Rihawi, MD
Facility Name
Fondazione del Piemonte per l'Oncologia (IRCCS)
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Fenocchio, MD
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Sobrero, MD
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Luca Frassineti, MD
Facility Name
Ospedale San Raffaele S.r.l. - PPDS
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Mazza, MD
Facility Name
Istituto Nazionale Dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Di Bartolomeo, MD
Facility Name
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Siena, MD
Facility Name
Azienda Ospedaliero Universitaria Di Modena Policlinico
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Spallanzani, MD
Facility Name
Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmine Pinto, MD
Facility Name
Fondazione Policlinico Universitario A Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giampaolo Tortora, MD
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libero Ciuffreda, MD
Facility Name
Centro Ricerche Cliniche Di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Melisi, MD
Facility Name
Azienda ULSS 8 "Berica" - Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Aprile, MD
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Tiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kohei Shitara, MD
Facility Name
National Cancer Center Hospital
City
Chuo Ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidekazu Hirano, MD
Facility Name
Shikoku Cancer Center
City
Matsuyama
ZIP/Postal Code
791-0245
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomohiro Nishina, MD
Facility Name
Aichi Cancer Center
City
Nagoya shi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukiya Narita, MD
Facility Name
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kensei Yamaguchi, MD
Facility Name
Kindai University Hospital
City
Ōsaka-sayama
ZIP/Postal Code
589-0014
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hisato Kawakami, MD
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-si
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Young Zang
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Yong Oh, MD, PhD
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Gwang Kim
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Lee Park, MD, PhD
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun-Jin Sym, MD
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beodeul Kang, PhD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun-Wook Lee, MD
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeul Hong Kim, MD, PhD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do-Youn Oh, MD
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inho Kim, MD, PhD
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Hoe Koo, MD
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
03686
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Young Rha, MD, PhD
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon-Koo Kang, MD, PhD
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06229
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hei-Cheul Jeung, MD, PhD
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Ki Kang, MD
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Cheul Oh, MD, PhD
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin Heng Fong, MD
Facility Name
Pantai Hospital Kuala Lumpur
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Seng Lam, MBBS
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Zamaniah Wan Ishak, MD
Facility Name
Sarawak General Hospital
City
Kuching
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei Jye Voon
Facility Name
National Cancer Institute ( Institut Kanser Negara)
City
Putrajaya
ZIP/Postal Code
62675
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoke Fui Wong
Facility Name
Cryptex Investigación Clínica, S.A. de C.V.
City
Mexico City
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Motola, MD
Facility Name
Clinstile, S.A. de C.V.
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Rosas
Facility Name
Research Site 2
City
Mexico City
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Dr. Jose Eleuterio González
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Manuel Oyervides Juarez, MD
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Romero Diaz
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geert Creemers, MD
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacco de Haan, MD
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marije Slingerland, MD
Facility Name
ETZ-Elisabeth
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robbert van Alphen, MD
Facility Name
Centrum Medyczne Poznan - PRATIA - PPDS
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Tomczak, MD, PhD
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Ulanska, MD
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helder Mansinho, MD
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-459
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Manuel Ferreira Cruz, MD
Facility Name
Hospital Senhora da Oliveira - Guimaraes, E.P.E
City
Guimarães
ZIP/Postal Code
4830-044
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Carvalho
Facility Name
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecília Alvim
Facility Name
Hospital Beatriz Angelo
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fábio Lopes
Facility Name
Unidade Local de Saúde de Matosinhos SA
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Magalhães, MD
Facility Name
Centro Hospitalar do Porto EPE
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Azevedo, MD
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filipa Carneiro
Facility Name
Fundeni Clinical Institute
City
București
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adina Croitoru, MD
Facility Name
Cardiomed SRL
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Calin Cainap, MD
Facility Name
Prof Dr I Chiricuta Institute of Oncology - PPDS
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tudor Ciuleanu, MD
Facility Name
Medisprof SRL
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anghel Adrian Udrea, MD
Facility Name
Onco Clinic Consult SA
City
Craiova
ZIP/Postal Code
200094
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Visan, MD
Facility Name
Oncology Center Sfantul Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Schenker, MD
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bogdan Gafton, MD
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoran Petrovic, MD
Facility Name
University Clinical Center of Serbia - PPDS
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nenad Mijalkovic, MD
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoran Andric, MD
Facility Name
Research Site
City
Belgrade
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
University Clinical Center Nis
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miljana Dzunic
Facility Name
Oncology Institute of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Nikolic, MD
Facility Name
Oncocare Cancer Centre
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Ng
Facility Name
Icon Cancer Centre Farrer Park
City
Singapore
ZIP/Postal Code
258500
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Son Hsieh, MD
Facility Name
Curie Oncology
City
Singapore
ZIP/Postal Code
329563
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Pin Choo
Facility Name
Cape Town Oncology Trials
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conrad Jacobs, MD
Facility Name
Southern Cross Research South Africa (PTY) LTD
City
Mogale City
ZIP/Postal Code
1724
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
University of Pretoria
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Khanyile
Facility Name
Wilgers Oncology Centre
City
Pretoria
ZIP/Postal Code
0184
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Fourie, MBBS, MD
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismael Macías Declara, MD
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Arrazubi Arrula, MD
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8915
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cinta Hierro Carbo, MD
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Tabernero Caturla, MD, PhD
Facility Name
Hospital Universitari de Girona Dr Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Guardeño, MD
Facility Name
ICO l'Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariona Calvo Campos, MD
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Longo Muñoz, MD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Gomez Martin, PhD
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Belén Custodio Carretero, MD
Facility Name
Hospital Regional Universitario de Malaga - Hospital General
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Ales, MD
Facility Name
Complejo Asistencial Universitario de Salamanca - H. Clinico
City
Salamanca
ZIP/Postal Code
32911
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Vidal Tocino, MD
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Rivera Herrero, MD, PhD
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan José Reina Zoilo
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Fleitas, MD
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Antonio Pazo Cid, MD
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404472
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Yuan Bai
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Tai Huang
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johnson Lin
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Huang Chen
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok Noi
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nopadol Soparattanapaisarn, MD
Facility Name
Bangkok Metropolitan Administration Medical College and Vajira Hospital
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yotsawaj Runglodvatana
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiyarat Prasongsook
Facility Name
Prince of Songkla University
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chirawadee Sathitruangsak
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarin Chindaprasirt
Facility Name
Research Site
City
Khon Kaen
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Chulaborn Hospital
City
Lak Si
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Archara Supavavej
Facility Name
Naresuan University
City
Phitsanulok
ZIP/Postal Code
65000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wittawat Jitpewngarm, MD
Facility Name
Hacettepe Universitesi Kanser Enstitusu
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suayib Yalcin, MD
Facility Name
Research site
City
Antalya
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Balçova
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Bursa
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Denizli
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Edirne
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Fatih
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Acibadem Maslak Hospital
City
Sariyer
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atakan Demir
Facility Name
Acibadem Adana Hospital
City
Seyhan
ZIP/Postal Code
01130
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umut Disel, MD
Facility Name
Research site
City
Sur
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Tarabya
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Trabzon
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Yenimahalle
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research site
City
Çankaya
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Communal Non-profit Enterprise Regional Center of Oncology
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"
City
Kyiv
ZIP/Postal Code
03039
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima
City
Kyiv
ZIP/Postal Code
03126
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
3115
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
City
Lutsk
ZIP/Postal Code
43018
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC
City
Odesa
ZIP/Postal Code
65055
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Falk, MBBS, MD
Facility Name
Western General Hospital Edinburgh - PPDS
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Wall, MD
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Ulahannan
Facility Name
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Maisey
Facility Name
Royal Marsden Hospital - London
City
London
ZIP/Postal Code
SW7 3RP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Cunningham, MD
Facility Name
Royal Marsden Hospital - Surrey
City
London
ZIP/Postal Code
SW7 3RP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Cunningham, MD
Facility Name
Mount Vernon Hospital
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Harrison, MD
Facility Name
Edith Cavell Hospital
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Ayers, MD
Facility Name
Weston Park Cancer Centre
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Darby, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36000541
Citation
Tabernero J, Shen L, Elimova E, Ku G, Liu T, Shitara K, Lin X, Boyken L, Li H, Grim J, Ajani J. HERIZON-GEA-01: Zanidatamab + chemo +/- tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. Future Oncol. 2022 Sep;18(29):3255-3266. doi: 10.2217/fon-2022-0595. Epub 2022 Aug 24.
Results Reference
derived
Learn more about this trial
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
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