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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03777657
Other study ID # BGB-A317-305
Secondary ID 2018-000312-24CT
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 13, 2018
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 997
Est. completion date December 31, 2024
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tislelizumab
200 mg IV on Day 1 during each 21-day cycle
Placebo
Placebo to match tislelizumab on Day 1 during each 21-day cycle
Cisplatin
80 mg/m² IV on Day 1 during each 21-day cycle
Oxaliplatin
130 mg/m² IV on Day 1 during each 21-day cycle
Capecitabine
1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle
5-FU
800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Beijing Chao Yang Hospital Beijing Beijing
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Beijing Luhe Hospital Beijing Beijing
China Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing
China Chinese PLA General Hospital Medical School of Chinese PLA Beijing Beijing
China No. 3 Hospital, Beijing University Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui
China The First Hospital of Jilin University Changchun Jilin
China Hunan Cancer Hospital Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China Daping Hospital of The 3rd Military University Chongqing Sichuan
China The First People's Hospital of Foshan Foshan Guangdong
China Fujian Cancer Hospital Fuzhou Fujian
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Guangdong General Hospital Guangzhou Guangdong
China Sun Yat-sen University, Cancer Center Guangzhou Guangdong
China The First Affiliated Hospital of Guilin Medical University Guilin Guangxi
China Hainan General Hospital Haikou Hainan
China Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou Zhejiang
China The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Anhui Provincial Cancer Hospital Hefei Anhui
China The Second Hospital of Anhui Medical University Hefei Anhui
China Shandong Cancer Hospital Jinan Shandong
China Yunnan Cancer Hospital Kunming Yunnan
China The First Hospital of Lanzhou University Lanzhou Gansu
China Linyi Cancer Hospital Linyi Shandong
China The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Jiangsu Cancer Hospital Nanjing Jiangsu
China Jiangsu Province Hospital Nanjing Jiangsu
China The Affiliated Drum Tower Hospital of Nanjing University Nanjing Jiangsu
China Nantong Tumor Hospital Nantong Jiangsu
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China Ruijin Hospital, Shanghai Jiaotong Uni. School of Med. Shanghai Shanghai
China Shanghai General Hospital Shanghai Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai
China Zhongshan Hospital Fudan University Shanghai Shanghai
China General Hospital of Shenyang Military Region Shenyang Liaoning
China Liaoning Cancer Hospital & Institute Shenyang Liaoning
China The First Hospital of China Medical University Shenyang Liaoning
China Shenzhen People's Hospital Shenzhen Guangdong
China Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
China Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin
China Tianjin Medical University General Hospital Tianjin Tianjin
China Hubei Cancer Hospital Wuhan Hubei
China Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
China Henan Cancer Hospital Zhengzhou Henan
China Henan Provincial People's Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
France CHU Besançon - Hôpital Jean Minjoz Besançon
France Centre Georges François Leclerc Dijon cedex Côte-d'Or
France Hôpital de la Timone Marseille
France Hôpital Nord Franche Comté Montbéliard
France Centre Antoine Lacassagne Nice cedex 02 Alpes Maritimes
France CHU Bordeaux - Hôpital Haut-Lévêque Pessac Gironde
Italy Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Bologna
Italy Istituto Nazionale Tumori Fondazione G. Pascale Napoli
Italy IOV - Istituto Oncologico Veneto IRCCS Padova
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Azienda Ospedaliera Universitaria Policlinico Tor Vergata Roma
Italy IRCCS Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Foggia
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona Torrette Ancona
Japan JOHAS Kansai Rosai Hospital Amagasaki-shi Hyogo-ken
Japan Chiba Cancer Center Chiba-shi Chiba-Ken
Japan National Cancer Center Hospital Chuo-ku Tokyo-To
Japan Tokyo Metropolitan Tama Medical Center Fuchu-shi Tokyo-to
Japan Fukui Prefectural Hospital Fukui-shi Fukui-ken
Japan NHO Kyushu Cancer Center Fukuoka-shi Fukuoka-Ken
Japan Hamamatsu University School of Medicine, University Hospital Hamamatsu-shi Shizuoka-Ken
Japan Saitama Medical University International Medical Center Hidaka-shi, Saitama-ken
Japan Hiroshima City Hiroshima Citizens Hospita Hiroshima-shi Hiroshima-ken,
Japan Saitama Cancer Center Ina Saitama
Japan Izumi City General Hospital Izumi-shi Osaka-Fu
Japan Tesshokai Kameda General Hospital Kamogawa-shi Chiba-ken
Japan Ishikawa Prefectural Central Hospital Kanazawa-shi Ishikawa-ken
Japan Kagawa University Hospital Kita-gun Kagawa-Ken
Japan Cancer Institute Hospital of JFCR Koto-ku Tokyo-To
Japan Kurashiki Central Hospital Kurashiki
Japan Kurashiki Central Hospital Kurashiki-shi Okayama-ken
Japan Okayama University Hospital Okayama-shi Okayama-ken
Japan Osaki Citizen Hospital Osaka
Japan Osaka Medical and Pharmaceutical University Hospital Osaka-fu Takatsuki-shi
Japan NHO Osaka National Hospital Osaka-shi Osaka-fu
Japan Gunma Prefectural Cancer Center Ota-shi Gunma -ken
Japan Hokkaido University Hospital Sapporo-shi Hokkaido
Japan Center Hospital of the National Center for Global Health and Medicine Shinjuku-ku Tokyo-To
Japan Osaka International Cancer Institute - Clinical Oncology Suita Osaka
Japan Osaka University Hospital Suita Osaka
Japan NHO Takasaki General Medical Center Takasaki-shi Gunma-ken
Japan Kanagawa Cancer Center Yokohama Kanagawa
Japan Oita University Hospital Yufu-shi Oita-Ken
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu Gyeongsangbuk-do
Korea, Republic of National Cancer Center Goyang-si Gyeonggi-do
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Jeollanam-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Seoul Gyeonggi-do
Korea, Republic of Ajou University Hospital Suwon Gyeonggi-do
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna Lodz
Poland Przychodnia Med-Polonia Sp. z o.o. Poznan
Poland Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Warszawa
Puerto Rico Pan American Oncology Trials, LLC San Juan
Russian Federation RBIH "Ivanovo Regional Oncological Dispensary" Ivanovo
Russian Federation "VitaMed" LLC Moscow
Russian Federation SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" Moscow
Russian Federation SBHI of Novosibirsk Novosibirsk
Russian Federation BHI of Omsk region "Clinical Oncology Dispensary" Omsk
Russian Federation FSBI "Clinical Research and Practical Center for specialized medical care (oncology)" Pesochnyy
Russian Federation Pavlov First Saint Petersburg State Medical University Saint Petersburg
Russian Federation Private Educational Institution of Higher Education "Medical University "REAVIZ" Samara
Russian Federation SBIH " Volgograd Regional Clinical Oncological Dispensary # 1" Volgograd
Russian Federation SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" Yaroslavl
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de Basurto Bilbao
Spain Hospital General Universitario de Elche Elche
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario HM Madrid Sanchinarro Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda
Spain Hospital Regional Universitario de Malaga Málaga
Spain Complejo Hospitalario de Navarra Pamplona
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Clinico Universitario de Valencia Valence
Spain Initia Oncologia, SLP Valencia
Spain Hospital Universitario Miguel Servet Zaragoza
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Taipei Veterans General Hospital Taipei
Turkey Acibadem Adana Hospital Adana
Turkey Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital Ankara
Turkey Akdeniz University Medical Faculty Antalya
Turkey Inonu Uni. Med. Fac. Malatya
United Kingdom Velindre Cancer Centre Cardiff
United Kingdom Sarah Cannon Research Institute UK London
United States Ohio State University Hospital Columbus Ohio
United States Tennessee Oncology, PLLC - Nashville Nashville Tennessee
United States Southeastern Regional Medical Center Newnan Georgia
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital - Central Philadelphia Pennsylvania
United States University of California Davis Health System Sacramento California
United States Reading Hospital West Reading Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  China,  France,  Italy,  Japan,  Korea, Republic of,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) The time from the date of randomization to the date of death due to any cause Up to 48 months
Secondary Progression-free survival (PFS) The time from the date of randomization to the date of the first objectively documented tumor progression Up to 30 months
Secondary 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 Up to 48 months
Secondary 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 Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Secondary Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Secondary Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30) Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Secondary Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L) Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months
Secondary Number of participants experiencing Adverse Events (AEs) Up to 48 months
Secondary Number of participants experiencing Serious Adverse Events (SAEs) Up to 48 months
Secondary Disease control rate (DCR) Proportion of complete response + partial response + stable disease Up to 48 Months
Secondary clinical benefit rate (CBR) Proportion of complete response + partial response + durable stable disease Up to 48 Months
Secondary time to response (TTR) Time from randomization to the first determination of an objective response Up to 48 Months