NCT03777657CompletedPhase 3
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
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
Source: ClinicalTrials.gov · Last updated 14 Feb 2025
Brief summary (registry, in English)
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 997 (actual)
- First submitted
- 9 Nov 2018
- Start date
- 13 Dec 2018
- Primary completion date
- 28 Feb 2023
- Lead sponsor
- BeiGene
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03777657
- EudraCT number
- 2018-000312-24
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 997
- From 13 Dec 2018 to the primary completion date, 28 Feb 2023
- 149 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (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.
Other illness
- Active leptomeningeal disease or uncontrolled brain metastasis
Other
- Has squamous cell or undifferentiated or other histological type GC
- Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
Who the study is looking for
- Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (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.
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization
- Adequate organ function ≤ 7 days prior to randomization
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (149)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Luhe Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Chao-Yang Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital of Bengbu Medical College Coordinator of this site? Confirm its status | Bengbu | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Daping Hospital, Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Foshan First Peoples Hospital Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Affiliated Hospital of Guilin Medical University Coordinator of this site? Confirm its status | Guilin | China | Unknown status |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Zhejiang University College of Medicine Second Affiliated Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Provincial Cancer Hospital aka West Branch of Anhui Province Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Second Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nantong Tumor Hospital Branch South Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| The Affiliated Hospital of Qingdao University Branch South Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Affiliated Zhongshan Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The General Hospital of Shenyang Military Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Liaoning Cancer Hospital and Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shenzhen Peoples Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital De Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario HM Madrid Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Complejo Hospitalario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Initia Oncologia, Slp Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Chu Besancon Hopital Jean Minjoz Coordinator of this site? Confirm its status | Doubs | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Icl Alexis Vautrin Coordinator of this site? Confirm its status | Meurthe Et Moselle | France | Unknown status |
| Hopital Nord Franche Comté - Site du Mittan Coordinator of this site? Confirm its status | Montbéliard | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| CHU Bordeaux - Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Velindre Cancer Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Sarah Cannon Research Institute UK Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Nazionale Tumori Fondazione G. Pascale Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| IOV - Istituto Oncologico Veneto IRCCS Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Ao Ospedali Riuniti Marche Nord Coordinator of this site? Confirm its status | Pesaro | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS Ospedale Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
| Aou Senese Policlinico Santa Maria Alle Scotte Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Azienda Ospedaliera Universitaria Delle Marche Coordinator of this site? Confirm its status | Torrette | Italy | Unknown status |
| Johas Kansai Rosai Hospital Coordinator of this site? Confirm its status | Amagasakishi | Japan | Unknown status |
| Chiba Cancer Center Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| Tokyo Metropolitan Tama Medical Center Coordinator of this site? Confirm its status | Fuchushi | Japan | Unknown status |
| NHO Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hamamatsu University School of Medicine, University Hospital Coordinator of this site? Confirm its status | Hamamatsushi | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidakashi | Japan | Unknown status |
| Izumi City General Hospital Coordinator of this site? Confirm its status | Izumishi | Japan | Unknown status |
| Tesshokai Kameda General Hospital Coordinator of this site? Confirm its status | Kamogawashi | Japan | Unknown status |
| Ishikawa Prefectural Central Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Kitaadachigun | Japan | Unknown status |
| Kagawa University Hospital Coordinator of this site? Confirm its status | Kitagun | Japan | Unknown status |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Kōtoku | Japan | Unknown status |
| Kurashiki Central Hospital Coordinator of this site? Confirm its status | Kurashikishi | Japan | Unknown status |
| NHO Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Nho Osaka National Hospital Coordinator of this site? Confirm its status | Osakashi | Japan | Unknown status |
| Gunma Prefectural Cancer Center Coordinator of this site? Confirm its status | Otashi | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Center Hospital of the National Center For Global Health and Medicine Coordinator of this site? Confirm its status | Shinjukuku | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suitashi | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Oita University Hospital Coordinator of this site? Confirm its status | Yufushi | Japan | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | HwasunGun | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| The Catholic University of Korea St Vincents Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Centrum Terapii Wspolczesnej Jm Jasnorzewska Sp Komandytowo Akcyjna Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Przychodnia Med Polonia Sp Z Oo Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Pan American Oncology Trials, Llc Coordinator of this site? Confirm its status | Rio Piedras | Puerto Rico | Unknown status |
| Arkhangelsk Regional Clinical Oncological Dispensary Coordinator of this site? Confirm its status | Arkhangelsk | Russia | Unknown status |
| RBIH "Ivanovo Regional Oncological Dispensary" Coordinator of this site? Confirm its status | Ivanovo | Russia | Unknown status |
| VitaMed LLC Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary" Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| BIH of Omsk Region "Clinical Oncology Dispensary" Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| Pavlov First Saint Petersburg State Medical University Coordinator of this site? Confirm its status | SaintPetersburg | Russia | Unknown status |
| Private Educational Institution of Higher Education Medical University Reaviz Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| Fsbi Clinical Research and Practical Center For Specialized Medical Care (Oncology) Coordinator of this site? Confirm its status | SanktPetersburg | Russia | Unknown status |
| State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Volgograd | Russia | Unknown status |
| SBIH of Yaroslavl region "Regional Clinical Oncological Hospital" Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Ohio State University Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Tennessee Oncology, Pllc Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Southeastern Regional Medical Center Coordinator of this site? Confirm its status | Newnan | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California Davis Health System Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Reading Hospital Coordinator of this site? Confirm its status | West Reading | United States | Unknown status |
| Acibadem Adana Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Nonu Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Battalgazi | Turkey (Türkiye) | Unknown status |
| Dicle University, Medical Faculty Coordinator of this site? Confirm its status | Diyarbakır | Turkey (Türkiye) | Unknown status |
| Akdeniz University Hospital Coordinator of this site? Confirm its status | Konyaalt | Turkey (Türkiye) | Unknown status |
| Iu C, Clinical Research Excellence Application and Research Center Coordinator of this site? Confirm its status | Stanbul | Turkey (Türkiye) | Unknown status |
| Namik Kemal University Coordinator of this site? Confirm its status | Tekirdağ | Turkey (Türkiye) | Unknown status |
| Karadeniz Tecnical Uni Med Fac Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.