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A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma (ESCC)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cisplatin
Oxaliplatin
Fluorouracil (5-FU)
Capecitabine
Paclitaxel
Tislelizumab
Placebo
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma (ESCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Participants with unresectable, locally advanced recurrent or metastatic ESCC who have Stage IV unresectable ESCC at first diagnosis (ie, Stage IV disease at the original diagnosis of ESCC) or who have unresectable, locally advanced recurrent or metastatic disease with at least a 6-month treatment-free interval, if prior definitive therapy (chemotherapy, chemo-radiation therapy or surgery) was given.

Key Inclusion Criteria:

  1. Pathologically (histologically) confirmed diagnosis of ESCC
  2. Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.

Key Exclusion Criteria:

  1. Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
  2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
  3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
  4. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
  5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
  6. Evidence of complete esophageal obstruction not amenable to treatment
  7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice
  8. Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
  9. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Smilow Cancer Hospital at Yale-New Haven - Neurology
  • Karmanos Cancer Institute
  • Allegheny General Hospital (AGH)
  • Medical University of South Carolina Hollings Cancer Center
  • University of Texas Health Science Center of San Antonio
  • Renovatio Clinical
  • Coffs Harbour Hospital
  • Townsville Hospital
  • Ashford Cancer Centre Research
  • Royal Hobart Hospital
  • St Vincent's Hospital
  • Ballarat Oncology & Haematology Services
  • Antwerp University Hospital
  • Institut Jules Bordet - Oncologie Médicale
  • Grand Hôpital de Charleroi - Site Notre-Dame
  • UZ Gent - Radiologie
  • UZ Leuven - Campus Gasthuisberg
  • AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
  • CHC Mont Legia
  • CHU Liège Sart Tilman
  • Anhui Provincial Cancer Hospital
  • Anhui Medical University - The Second Hospital
  • The Second Affiliated Hospital of Anhui Medical University
  • Beijing Friendship Hospital - Oncology
  • The Fifth Medical Center of Chinese PLA General Hospital
  • Beijing Cancer Hospital
  • Peking Union Medical College Hospital - Oncology
  • Fujian Provincial Cancer Hospital - Oncology
  • The First Affiliated Hospital of Fujian Medical University
  • Zhongshan Hospital Xiamen University
  • The First Affiliated Hospital of Sun Yat-sen University
  • Guangdong Province Traditional Chinese Medical Hospital
  • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • Cancer Hospital of Shantou University Medical College
  • Cancer Hospital of Guangxi Medical University
  • Hainan General Hospital - Oncology
  • Affiliated Tumor Hospital of Harbin Medical University
  • The First Affiliated Hospital of Zhengzhou University - Oncology
  • The First Affiliated Hospital of Xinxiang Medical University
  • Henan Cancer Hospital - Oncology
  • Hubei Cancer Hospital - Oncology
  • Xiangyang Central Hospital
  • Hunan Cancer Hospital - GCP Office
  • The First People's Hospital of Changzhou - Oncology
  • Jiangsu Province Hospital
  • Nantong Cancer Hospital
  • Affiliated Hospital of Jiangnan University
  • The Affiliated Hospital of Xuzhou Medical University - Radiology
  • Northern Jiangsu People's Hospital
  • The Second Affiliated Hospital of Nanchang University
  • Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
  • Quanzhou First Hospital - Radiotherapy/Nuclear Medicine
  • Shandong Cancer Hospital and Institute, Shandong First Medical University
  • Linyi Cancer Hospital
  • WeiFang People's Hospital
  • Fudan University Shanghai Cancer Center
  • Shanxi Provincial People's Hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • The First Affiliated Hospital of Zhejiang University
  • Sir Run Run Shaw Hospital, Zhejiang University
  • Zhejiang Cancer Hospital
  • Anhui Provincial Hospital - Oncology
  • The First Affiliated Hospital of Xiamen University - Oncology
  • Fakultní Nemocnice Olomouc
  • Thomayerova nemocnice
  • Nemocnice Na Bulovce
  • Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
  • CHRU de Besançon- Hôpital Jean Minjoz
  • CHU Bordeaux Hôpital Du Haut-Lévêque
  • Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber
  • ICO
  • Center Oscar Lambret - Alliance Member
  • Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie
  • Centre Léon Bérard
  • Centre Hospitalier Universitaire de Poitiers
  • Hopital Europeen Georges Pompidou - Digestive Oncology
  • Groupe Hospitalier Paris Saint Joseph - Oncologie
  • SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin
  • University Hospital Tuebingen
  • Johannes Wesling Klinikum Minden
  • Universitätsmedizin Mainz
  • University Hospital Of Leipzig
  • University Hospital Hamburg- Eppendorf
  • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica
  • Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio
  • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica
  • Ieo, Irccs
  • Asst Grande Ospedale Metropolitano Niguarda
  • Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
  • Istituto Oncologico Veneto IOV-IRCCS
  • SO S.Chiara, AOU Pisana - Oncologia 2
  • National Cancer Center Hospital East - Gastrointestinal Oncology
  • Kyushu Medical Center - Gastroenterological Surgery
  • National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology
  • Kobe City Medical Center General Hospital - Medical Oncology
  • Kagawa University Hospital - Oncology
  • Kanagawa Cancer Center - Gastroenterological surgery
  • University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology
  • Kindai University Nara Hospital
  • Osaka University Hospital - Medical Oncology
  • National Cancer Center Hospital - Gastrointestinal Oncology
  • Hyogo Cancer Center
  • Akita University Hospital - Pediatrics
  • Kansai Rosai Hospital - Gastroenterological Surgery
  • Hiroshima University Hospital - Gastrointestinal Surgery
  • Kumamoto University Hospital
  • Kyoto University Hospital
  • Niigata Cancer Center Hospital
  • Osaka International Cancer Institute - Clinical Oncology
  • Saitama Cancer Center - Gastroenterology
  • Seoul National University Bundang Hospital - Hematology/Oncology
  • CHA Bundang Medical Center, CHA University - Oncology
  • Gachon University Gil Medical Center - Oncology
  • Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Samsung Medical Center - Hematology-Oncology
  • SMG-SNU Boramae Medical Center - Oncology
  • Korea University Guro Hospital - Hematology-Oncology
  • Keimyung University Dongsan Medical Center
  • Asan Medical Center - Oncology
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
  • Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
  • Szpital Wojewodzki w Koszalinie
  • SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
  • Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
  • Radiotherapy Center Cluj
  • Centrul de Oncologie Sf. Nectarie
  • Institutul Clinic Fundeni
  • Spitalul Clinic Coltea
  • Medisprof
  • Centrul de Oncologie Euroclinic
  • Arkhangelsk Regional Clinical Oncological Dispensary
  • Leningrad Regional Oncology Dispensary
  • Orenburg Regional Clinical Oncology Center
  • Rostov Research Institute of Oncology (RRIO)
  • The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov
  • City Oncology Dispensary
  • Ivanovo Regional Oncology Dispensary
  • Petrov Research Institute of Oncology
  • Hospital Universitario Central de Asturias
  • Institut Catalá d´Oncología (I.C.O.)
  • Hospital Madrid Norte Sanchinarro
  • Hospital Universitario Vall d'Hebrón
  • Hospital Clinic de Barcelona
  • Hospital General Universitario Gregorio Marañon
  • H.U.V.Arrixaca
  • Hospital Universitario Virgen De La Victoria
  • Hospital Universitario Miguel Servet
  • Kaohsiung Veterans General Hospital - Thoracic Surgery
  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
  • China Medical University Hospital - Oncology - Taichung
  • Chi Mei Medical Center - YongKang - Chi Mei Medical Center
  • Chi Mei Hospital, Liouying - Department of Oncology
  • Guys and St Thomas' Hospital
  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi
  • Mount Vernon Cancer Centre
  • Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre
  • Beatson West of Scotland Cancer Centre - Oncology
  • The Christie NHS Foundation Trust - Oak Road Treatment Centr

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tislelizumab + chemotherapy

Placebo + chemotherapy

Arm Description

Tislelizumab administered with chemotherapy doublet: Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel

Placebo administered with chemotherapy doublet: Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death due to any cause

Secondary Outcome Measures

Full Information

First Posted
December 18, 2018
Last Updated
April 14, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03783442
Brief Title
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official Title
A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma (ESCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab + chemotherapy
Arm Type
Experimental
Arm Description
Tislelizumab administered with chemotherapy doublet: Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel
Arm Title
Placebo + chemotherapy
Arm Type
Active Comparator
Arm Description
Placebo administered with chemotherapy doublet: Doublet A: Cisplatin or Oxaliplatin plus Fluorouracil (5-FU); Doublet B: Cisplatin or Oxaliplatin plus Capecitabine; Doublet C: Cisplatin or Oxaliplatin plus Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
60 to 80 mg/m^2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m^2 IV on Day 1 Q3W
Intervention Type
Drug
Intervention Name(s)
Fluorouracil (5-FU)
Intervention Description
750 to 800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175 mg/m^2 IV on Day 1 Q3W
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
200 mg IV Q3W
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match Tislelizumab
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization until the date of death due to any cause
Time Frame
Up to approximately 40 months from date of the first participant randomization
Other Pre-specified Outcome Measures:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Overall survival (OS) in the PD-L1 score ≥ 10% subgroup
Description
OS is defined as the time from the date of randomization until the date of death due to any cause
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using European Quality of Life-Core 30 Questionnaire index (EORTC QLQ-C30)
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire esophageal cancer specific module (EORTC QLQ-OES18)
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Health-Related Quality of Life (HRQoL) assessment of the participant's overall health status using the generic health state instrument European Quality of Life-5 Dimensions (EuroQol 5D EQ-5D-5L)
Time Frame
Approximately 40 months from date of the first participant randomization
Title
Number of participants experiencing Adverse Events (AEs)
Time Frame
Approximately 40 months from date of the first participant randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participants with unresectable, locally advanced recurrent or metastatic ESCC who have Stage IV unresectable ESCC at first diagnosis (ie, Stage IV disease at the original diagnosis of ESCC) or who have unresectable, locally advanced recurrent or metastatic disease with at least a 6-month treatment-free interval, if prior definitive therapy (chemotherapy, chemo-radiation therapy or surgery) was given. Key Inclusion Criteria: Pathologically (histologically) confirmed diagnosis of ESCC Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required. Key Exclusion Criteria: Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2 Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta) Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention) Evidence of complete esophageal obstruction not amenable to treatment Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) < 83.5 per investigator's choice Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator. Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyun Li, MD
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Smilow Cancer Hospital at Yale-New Haven - Neurology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3220
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Allegheny General Hospital (AGH)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4756
Country
United States
Facility Name
Medical University of South Carolina Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Health Science Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77389
Country
United States
Facility Name
Coffs Harbour Hospital
City
Coffs Harbour
State/Province
Pacific Highway
ZIP/Postal Code
2450
Country
Australia
Facility Name
Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Ballarat Oncology & Haematology Services
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Institut Jules Bordet - Oncologie Médicale
City
Anderlecht
State/Province
Brussels Capital Region
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Grand Hôpital de Charleroi - Site Notre-Dame
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Gent - Radiologie
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CHC Mont Legia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Liège Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
Anhui Medical University - The Second Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Beijing Friendship Hospital - Oncology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
The Fifth Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking Union Medical College Hospital - Oncology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Provincial Cancer Hospital - Oncology
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
35005
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong Province Traditional Chinese Medical Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
Cancer Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
Hainan General Hospital - Oncology
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Affiliated Tumor Hospital of Harbin Medical University
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University - Oncology
City
Henan
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
Henan Cancer Hospital - Oncology
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Cancer Hospital - Oncology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441021
Country
China
Facility Name
Hunan Cancer Hospital - GCP Office
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First People's Hospital of Changzhou - Oncology
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Nantong Cancer Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214062
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University - Radiology
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110017
Country
China
Facility Name
Quanzhou First Hospital - Radiotherapy/Nuclear Medicine
City
Quanzhou
State/Province
Quanzhou
Country
China
Facility Name
Shandong Cancer Hospital and Institute, Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
276001
Country
China
Facility Name
WeiFang People's Hospital
City
Weifang
State/Province
Shandong
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Anhui Provincial Hospital - Oncology
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University - Oncology
City
Xiamen
ZIP/Postal Code
361005
Country
China
Facility Name
Fakultní Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie
City
Brest Cedex
State/Province
Bretagne
ZIP/Postal Code
29609
Country
France
Facility Name
CHRU de Besançon- Hôpital Jean Minjoz
City
Besançon Cedex
State/Province
Doubs
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Bordeaux Hôpital Du Haut-Lévêque
City
Pessac Cedex
State/Province
Gironde
ZIP/Postal Code
33608
Country
France
Facility Name
Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber
City
Levallois-Perret
State/Province
Hauts-de-Seine
ZIP/Postal Code
92300
Country
France
Facility Name
ICO
City
Saint-Herblain
State/Province
Loire-Atlantique
ZIP/Postal Code
44805
Country
France
Facility Name
Center Oscar Lambret - Alliance Member
City
Lille
State/Province
Nord
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie
City
Paris Cedex 12
State/Province
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86000
Country
France
Facility Name
Hopital Europeen Georges Pompidou - Digestive Oncology
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Groupe Hospitalier Paris Saint Joseph - Oncologie
City
Paris
ZIP/Postal Code
75074
Country
France
Facility Name
SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin
City
Heilbronn
State/Province
Baden-Württemberg
ZIP/Postal Code
74078
Country
Germany
Facility Name
University Hospital Tuebingen
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32429
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55101
Country
Germany
Facility Name
University Hospital Of Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Hospital Hamburg- Eppendorf
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica
City
Torino
State/Province
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ieo, Irccs
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Asst Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV-IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
SO S.Chiara, AOU Pisana - Oncologia 2
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
National Cancer Center Hospital East - Gastrointestinal Oncology
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kyushu Medical Center - Gastroenterological Surgery
City
Fukuoka
State/Province
Hukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology
City
Fukuoka
State/Province
Hukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kobe City Medical Center General Hospital - Medical Oncology
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kagawa University Hospital - Oncology
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kanagawa Cancer Center - Gastroenterological surgery
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology
City
Kamigyō-ku
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kindai University Nara Hospital
City
Ikoma
State/Province
Osaka
ZIP/Postal Code
630-0293
Country
Japan
Facility Name
Osaka University Hospital - Medical Oncology
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Cancer Center Hospital - Gastrointestinal Oncology
City
Chuo Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Hyogo Cancer Center
City
Akashi
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Akita University Hospital - Pediatrics
City
Akita-shi
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Kansai Rosai Hospital - Gastroenterological Surgery
City
Amagasaki
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Hiroshima University Hospital - Gastrointestinal Surgery
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute - Clinical Oncology
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Saitama Cancer Center - Gastroenterology
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Seoul National University Bundang Hospital - Hematology/Oncology
City
Seongnam-si
State/Province
Gyeonggido [Kyonggi-do]
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center, CHA University - Oncology
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center - Oncology
City
Incheon
State/Province
Incheon Gwang'yeogsi [Inch'n-K
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic
City
Hwasun
State/Province
Jeonranamdo [Chollanam-do]
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp]
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Samsung Medical Center - Hematology-Oncology
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center - Oncology
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital - Hematology-Oncology
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Asan Medical Center - Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi
City
Brzozow
State/Province
Podkarpackie
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Szpital Wojewodzki w Koszalinie
City
Koszalin
State/Province
Pomorskie
ZIP/Postal Code
75-581
Country
Poland
Facility Name
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Radiotherapy Center Cluj
City
Floreşti
State/Province
Cluj
ZIP/Postal Code
407280
Country
Romania
Facility Name
Centrul de Oncologie Sf. Nectarie
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Medisprof
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Facility Name
Centrul de Oncologie Euroclinic
City
Iaşi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Oncological Dispensary
City
Arkhangelsk
State/Province
Arkhangel'skaya Oblast'
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Leningrad Regional Oncology Dispensary
City
Kuz'molovskiy
State/Province
Leningradskaya Oblast
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Orenburg Regional Clinical Oncology Center
City
Orenburg
State/Province
Orenburgskaya Oblast
ZIP/Postal Code
460021
Country
Russian Federation
Facility Name
Rostov Research Institute of Oncology (RRIO)
City
Rostov-Na-Donu
State/Province
Rostovskaya Oblast
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
City Oncology Dispensary
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Dispensary
City
Ivanovo
ZIP/Postal Code
153015
Country
Russian Federation
Facility Name
Petrov Research Institute of Oncology
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Institut Catalá d´Oncología (I.C.O.)
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Sanchinarro
State/Province
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
H.U.V.Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario Virgen De La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kaohsiung Veterans General Hospital - Thoracic Surgery
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital - Oncology - Taichung
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi Mei Medical Center - YongKang - Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Chi Mei Hospital, Liouying - Department of Oncology
City
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
Guys and St Thomas' Hospital
City
London
State/Province
City Of London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospi
City
London
State/Province
City Of London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre - Oncology
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust - Oak Road Treatment Centr
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

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