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Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

Primary Purpose

Gastric, or Gastroesophageal Junction Adenocarcinoma

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

About this trial

This is an interventional treatment trial for Gastric, or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
  2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
  3. ECOG PS ≤ 1 within 7 days prior to randomization
  4. Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization

Key Exclusion Criteria:

  1. Has squamous cell or undifferentiated or other histological type GC
  2. Active leptomeningeal disease or uncontrolled brain metastasis
  3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
  4. Prior therapy 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

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

Sites / Locations

  • University of California Davis Health System
  • Southeastern Regional Medical Center
  • Ohio State University Hospital
  • Thomas Jefferson University Hospital - Central
  • Fox Chase Cancer Center
  • Reading Hospital
  • Tennessee Oncology, PLLC - Nashville
  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui Provincial Cancer Hospital
  • The Second Hospital of Anhui Medical University
  • Beijing Chao Yang Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences
  • Peking Union Medical College Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • No. 3 Hospital, Beijing University
  • Beijing Cancer Hospital
  • Chinese PLA General Hospital Medical School of Chinese PLA
  • Beijing Luhe Hospital
  • The First Affiliated Hospital of Fujian Medical University
  • Fujian Cancer Hospital
  • The First Hospital of Lanzhou University
  • The First People's Hospital of Foshan
  • Sun Yat-sen University, Cancer Center
  • Guangdong General Hospital
  • Shenzhen People's Hospital
  • The First Affiliated Hospital of Guilin Medical University
  • Hainan General Hospital
  • Fourth Hospital of Hebei Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Provincial People's Hospital
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hubei Cancer Hospital
  • Hunan Cancer Hospital
  • Xiangya Hospital Central South University
  • The Affiliated Drum Tower Hospital of Nanjing University
  • Jiangsu Cancer Hospital
  • Jiangsu Province Hospital
  • Nantong Tumor Hospital
  • The Second Affiliated Hospital of Nanchang University
  • The First Hospital of Jilin University
  • The First Hospital of China Medical University
  • General Hospital of Shenyang Military Region
  • Liaoning Cancer Hospital & Institute
  • Shandong Cancer Hospital
  • Linyi Cancer Hospital
  • The Affiliated Hospital of Qingdao University
  • Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
  • Zhongshan Hospital Fudan University
  • Shanghai General Hospital
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Daping Hospital of The 3rd Military University
  • Tianjin Medical University General Hospital
  • Tianjin Medical University Cancer Institute & Hospital
  • Yunnan Cancer Hospital
  • The First Affiliated Hospital, Zhejiang University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
  • Zhejiang Cancer Hospital
  • Centre Antoine Lacassagne
  • Centre Georges François Leclerc
  • CHU Bordeaux - Hôpital Haut-Lévêque
  • CHU Besançon - Hôpital Jean Minjoz
  • Hôpital de la Timone
  • Hôpital Nord Franche Comté
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • Istituto Nazionale Tumori Fondazione G. Pascale
  • IOV - Istituto Oncologico Veneto IRCCS
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Chiba Cancer Center
  • Tesshokai Kameda General Hospital
  • Fukui Prefectural Hospital
  • NHO Kyushu Cancer Center
  • Gunma Prefectural Cancer Center
  • NHO Takasaki General Medical Center
  • Hiroshima City Hiroshima Citizens Hospita
  • Hokkaido University Hospital
  • JOHAS Kansai Rosai Hospital
  • Ishikawa Prefectural Central Hospital
  • Kagawa University Hospital
  • Kanagawa Cancer Center
  • Oita University Hospital
  • Kurashiki Central Hospital
  • Okayama University Hospital
  • Izumi City General Hospital
  • NHO Osaka National Hospital
  • Osaka International Cancer Institute - Clinical Oncology
  • Osaka University Hospital
  • Saitama Medical University International Medical Center
  • Saitama Cancer Center
  • Hamamatsu University School of Medicine, University Hospital
  • Osaka Medical and Pharmaceutical University Hospital
  • National Cancer Center Hospital
  • Tokyo Metropolitan Tama Medical Center
  • Cancer Institute Hospital of JFCR
  • Center Hospital of the National Center for Global Health and Medicine
  • Kurashiki Central Hospital
  • Osaki Citizen Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Severance Hospital, Yonsei University
  • The Catholic University of Korea, St. Vincent's Hospital
  • Ajou University Hospital
  • Kyungpook National University Chilgok Hospital
  • Chonnam National University Hwasun Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Chung-Ang University Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Uniwersyteckie Centrum Kliniczne
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
  • Przychodnia Med-Polonia Sp. z o.o.
  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
  • Pan American Oncology Trials, LLC
  • RBIH "Ivanovo Regional Oncological Dispensary"
  • "VitaMed" LLC
  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
  • SBHI of Novosibirsk
  • BHI of Omsk region "Clinical Oncology Dispensary"
  • FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
  • Pavlov First Saint Petersburg State Medical University
  • Private Educational Institution of Higher Education "Medical University "REAVIZ"
  • SBIH " Volgograd Regional Clinical Oncological Dispensary # 1"
  • SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
  • Hospital Clinic de Barcelona
  • Hospital de Basurto
  • Hospital General Universitario de Elche
  • Hospital General Universitario Gregorio Marañon
  • Hospital Universitario La Paz
  • Hospital Universitario HM Madrid Sanchinarro
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Regional Universitario de Malaga
  • Complejo Hospitalario de Navarra
  • Hospital Universitario Virgen del Rocio
  • Hospital Clinico Universitario de Valencia
  • Initia Oncologia, SLP
  • Hospital Universitario Miguel Servet
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Cheng Kung University Hospital
  • Taipei Veterans General Hospital
  • Acibadem Adana Hospital
  • Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
  • Akdeniz University Medical Faculty
  • Inonu Uni. Med. Fac.
  • Velindre Cancer Centre
  • Sarah Cannon Research Institute UK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tislelizumab (BGB-A317) + chemotherapy

Placebo + chemotherapy

Arm Description

Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.

Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
The time from the date of randomization to the date of death due to any cause

Secondary Outcome Measures

Progression-free survival (PFS)
The time from the date of randomization to the date of the first objectively documented tumor progression
Overall response rate (ORR)
The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1
Duration of response (DOR)
The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)
Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)
Number of participants experiencing Adverse Events (AEs)
Number of participants experiencing Serious Adverse Events (SAEs)
Disease control rate (DCR)
Proportion of complete response + partial response + stable disease
clinical benefit rate (CBR)
Proportion of complete response + partial response + durable stable disease
time to response (TTR)
Time from randomization to the first determination of an objective response

Full Information

First Posted
November 9, 2018
Last Updated
September 13, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03777657
Brief Title
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2018 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
December 31, 2024 (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

5. Study Description

Brief Summary
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric, or Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab (BGB-A317) + chemotherapy
Arm Type
Experimental
Arm Description
Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy.
Arm Title
Placebo + chemotherapy
Arm Type
Placebo Comparator
Arm Description
Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg IV on Day 1 during each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match tislelizumab on Day 1 during each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80 mg/m² IV on Day 1 during each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m² IV on Day 1 during each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The time from the date of randomization to the date of death due to any cause
Time Frame
Up to 48 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
The time from the date of randomization to the date of the first objectively documented tumor progression
Time Frame
Up to 30 months
Title
Overall response rate (ORR)
Description
The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1
Time Frame
Up to 48 months
Title
Duration of response (DOR)
Description
The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first
Time Frame
Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Title
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22)
Time Frame
Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Title
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30)
Time Frame
Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Title
Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L)
Time Frame
Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Title
Number of participants experiencing Adverse Events (AEs)
Time Frame
Up to 48 months
Title
Number of participants experiencing Serious Adverse Events (SAEs)
Time Frame
Up to 48 months
Title
Disease control rate (DCR)
Description
Proportion of complete response + partial response + stable disease
Time Frame
Up to 48 Months
Title
clinical benefit rate (CBR)
Description
Proportion of complete response + partial response + durable stable disease
Time Frame
Up to 48 Months
Title
time to response (TTR)
Description
Time from randomization to the first determination of an objective response
Time Frame
Up to 48 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months. ECOG PS ≤ 1 within 7 days prior to randomization Adequate organ function as indicated by the following laboratory values ≤ days prior to randomization Key Exclusion Criteria: Has squamous cell or undifferentiated or other histological type GC Active leptomeningeal disease or uncontrolled brain metastasis Diagnosed with gastric or GEJ adenocarcinoma with positive HER2 Prior therapy 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Wang, MD
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Southeastern Regional Medical Center
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Ohio State University Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson University Hospital - Central
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Tennessee Oncology, PLLC - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
231200
Country
China
Facility Name
Beijing Chao Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
No. 3 Hospital, Beijing University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Chinese PLA General Hospital Medical School of Chinese PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Beijing Luhe Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
73000
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Sun Yat-sen University, Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The First Affiliated Hospital of Guilin Medical University
City
Guilin
State/Province
Guangxi
ZIP/Postal Code
41000
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50051
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226361
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Shandong Cancer Hospital
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
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200020
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Daping Hospital of The 3rd Military University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400042
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
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
Centre Antoine Lacassagne
City
Nice cedex 02
State/Province
Alpes Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon cedex
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Bordeaux - Hôpital Haut-Lévêque
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Facility Name
Hôpital Nord Franche Comté
City
Montbéliard
Country
France
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
City
Torrette
State/Province
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
IOV - Istituto Oncologico Veneto IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
133
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Chiba Cancer Center
City
Chiba-shi
State/Province
Chiba-Ken
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Tesshokai Kameda General Hospital
City
Kamogawa-shi
State/Province
Chiba-ken
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui-shi
State/Province
Fukui-ken
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
NHO Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka-Ken
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota-shi
State/Province
Gunma -ken
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
NHO Takasaki General Medical Center
City
Takasaki-shi
State/Province
Gunma-ken
ZIP/Postal Code
370-0829
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospita
City
Hiroshima-shi
State/Province
Hiroshima-ken,
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
JOHAS Kansai Rosai Hospital
City
Amagasaki-shi
State/Province
Hyogo-ken
ZIP/Postal Code
660-8511
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa-shi
State/Province
Ishikawa-ken
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Kagawa University Hospital
City
Kita-gun
State/Province
Kagawa-Ken
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Oita University Hospital
City
Yufu-shi
State/Province
Oita-Ken
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki-shi
State/Province
Okayama-ken
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-shi
State/Province
Okayama-ken
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Izumi City General Hospital
City
Izumi-shi
State/Province
Osaka-Fu
ZIP/Postal Code
594-0073
Country
Japan
Facility Name
NHO Osaka National Hospital
City
Osaka-shi
State/Province
Osaka-fu
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka International Cancer Institute - Clinical Oncology
City
Suita
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka-shi,
State/Province
Saitama-ken
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center
City
Ina
State/Province
Saitama
Country
Japan
Facility Name
Hamamatsu University School of Medicine, University Hospital
City
Hamamatsu-shi
State/Province
Shizuoka-Ken
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Osaka Medical and Pharmaceutical University Hospital
City
Osaka-fu
State/Province
Takatsuki-shi
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo-To
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Metropolitan Tama Medical Center
City
Fuchu-shi
State/Province
Tokyo-to
ZIP/Postal Code
183-8524
Country
Japan
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo-To
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-ku
State/Province
Tokyo-To
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Kurashiki Central Hospital
City
Kurashiki
ZIP/Postal Code
710-8602
Country
Japan
Facility Name
Osaki Citizen Hospital
City
Osaka
ZIP/Postal Code
989-6183
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Przychodnia Med-Polonia Sp. z o.o.
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
City
Warszawa
ZIP/Postal Code
02-034
Country
Poland
Facility Name
Pan American Oncology Trials, LLC
City
San Juan
ZIP/Postal Code
902
Country
Puerto Rico
Facility Name
RBIH "Ivanovo Regional Oncological Dispensary"
City
Ivanovo
ZIP/Postal Code
153040
Country
Russian Federation
Facility Name
"VitaMed" LLC
City
Moscow
ZIP/Postal Code
129515
Country
Russian Federation
Facility Name
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"
City
Moscow
Country
Russian Federation
Facility Name
SBHI of Novosibirsk
City
Novosibirsk
Country
Russian Federation
Facility Name
BHI of Omsk region "Clinical Oncology Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"
City
Pesochnyy
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Pavlov First Saint Petersburg State Medical University
City
Saint Petersburg
Country
Russian Federation
Facility Name
Private Educational Institution of Higher Education "Medical University "REAVIZ"
City
Samara
ZIP/Postal Code
443011
Country
Russian Federation
Facility Name
SBIH " Volgograd Regional Clinical Oncological Dispensary # 1"
City
Volgograd
Country
Russian Federation
Facility Name
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Facility Name
Hospital General Universitario de Elche
City
Elche
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario HM Madrid Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valence
Country
Spain
Facility Name
Initia Oncologia, SLP
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
1130
Country
Turkey
Facility Name
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
City
Ankara
ZIP/Postal Code
6105
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
7058
Country
Turkey
Facility Name
Inonu Uni. Med. Fac.
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Velindre Cancer Centre
City
Cardiff
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute UK
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

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