NCT03783442CompletedPhase 3
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
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
Source: ClinicalTrials.gov · Last updated 29 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 649 (actual)
- First submitted
- 18 Dec 2018
- Start date
- 11 Dec 2018
- Primary completion date
- 28 Feb 2022
- Lead sponsor
- BeiGene
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT03783442
- EudraCT number
- 2018-000587-28
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 649
- From 11 Dec 2018 to the primary completion date, 28 Feb 2022
- 124 sites in 16 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
- 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
- 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.
Other illness
- Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (124)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Coffs Harbour Base Hospital Coordinator of this site? Confirm its status | Coffs Harbour | Australia | Unknown status |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Unknown status |
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Grand Hopital de Charleroi - Site Notre Dame Coordinator of this site? Confirm its status | Charleroi | Belgium | Unknown status |
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| The Fifth medical center of Chinese PLA General Hospital 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 Friendship Hospital, Capital Medical University 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 |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The First Peoples Hospital of Changzhou Coordinator of this site? Confirm its status | Changzhou | 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 |
| The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Province Traditional Chinese Medical Hospitsal Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Sixth Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | 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 |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine 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 |
| 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 |
| Anhui Provincial Hospital 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 |
| 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 |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Tumor Hospital Affiliated to Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Nantong Tumor Hospital Branch North Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Quanzhou First Affliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Quanzhou | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Cancer Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
| Liaoning Cancer Hospital and Institute Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shanxi Provincial Peoples Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Weifang Peoples Hospital Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital ) Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Universitätsklinikum Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin Coordinator of this site? Confirm its status | Heilbronn | Germany | Unknown status |
| Universitäres Krebszentrum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Institut Catala Doncologia Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Vall Dhebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Chru de Brest Hopital Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Chu Besancon Hopital Jean Minjoz Coordinator of this site? Confirm its status | Doubs | France | Unknown status |
| Hopital Franco Britannique Coordinator of this site? Confirm its status | LevalloisPerret | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Saint Antoine Service Dhepato Gastro Enterologie Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Bordeaux - Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Unknown status |
| Chu de Poitiers Site de La Mileterie Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau Coordinator of this site? Confirm its status | SaintHerblain | France | Unknown status |
| The Christie Hospital Coordinator of this site? Confirm its status | Greater Manchester | United Kingdom | Unknown status |
| Guys and St Thomas Hospital Nhs Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
| Istituto Europeo di Oncologia 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 |
| Azienda Ospedaliera Universitaria Delle Marche Coordinator of this site? Confirm its status | Torrette | Italy | Unknown status |
| Hyogo Cancer Center Coordinator of this site? Confirm its status | AkashiShi | Japan | Unknown status |
| Akita University Hospital Coordinator of this site? Confirm its status | Akitashi | Japan | Unknown status |
| Johas Kansai Rosai Hospital Coordinator of this site? Confirm its status | Amagasakishi | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chūōku | Japan | Unknown status |
| NHO Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Hospital Organization Kyushu Medical Center Coordinator of this site? Confirm its status | Fukuokacity | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Kitaadachigun | Japan | Unknown status |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| University Hospital, Kyoto Prefectural Univ of Medicine Coordinator of this site? Confirm its status | KyotoShi | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Osaka International Cancer Institute Coordinator of this site? Confirm its status | Osakashi | Japan | Unknown status |
| The University of Osaka 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 |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | BundangGu SeongnamSi | South Korea | Unknown status |
| Cha Bundang Medical Center, Cha University Coordinator of this site? Confirm its status | BundangGu SeongnamSi | South Korea | Unknown status |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Dalseogu | South Korea | Unknown status |
| Smg Snu Boramae Medical Center Coordinator of this site? Confirm its status | DongjakGu | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | GuroGu | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | HwasunGun | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | NamdongGu | South Korea | Unknown status |
| The Catholic University of Korea, Seoul St Marys Hospital Coordinator of this site? Confirm its status | SeochoGu | South Korea | Unknown status |
| Samsung Medical Center - Hematology & Oncology Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | SongpaGu | South Korea | Unknown status |
| Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny Coordinator of this site? Confirm its status | Brzozów | Poland | Unknown status |
| Szpital Wojewodzki Im Mikoaja Kopernika W Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Unknown status |
| Spzoz Mswia Z Warminsko Mazurskim Centrum Onkologii Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
| Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Medisprof Cancer Center Coordinator of this site? Confirm its status | ClujNapoca | Romania | Unknown status |
| Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca Coordinator of this site? Confirm its status | ClujNapoca | Romania | Unknown status |
| Radiotherapy Center Cluj Coordinator of this site? Confirm its status | ClujNapoca | Romania | Unknown status |
| Sc Centrul de Oncologie Sf Nectarie Srl Coordinator of this site? Confirm its status | Craiova | Romania | 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 |
| State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary Coordinator of this site? Confirm its status | Kuzmolovsky | Russia | Unknown status |
| Orenburg Regional Clinical Oncology Center Coordinator of this site? Confirm its status | Orenburg | Russia | Unknown status |
| Rostov State Medical University Coordinator of this site? Confirm its status | RostovonDon | Russia | Unknown status |
| Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf Coordinator of this site? Confirm its status | SaintPetersburg | Russia | Unknown status |
| Pavlov First Saint Petersburg State Medical University Coordinator of this site? Confirm its status | SaintPetersburg | Russia | Unknown status |
| Chiayi Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Chi Mei Hospital Liouying Coordinator of this site? Confirm its status | Liuying Dist | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | North Dist. | Taiwan | Unknown status |
| Chi Mei Medical Center Coordinator of this site? Confirm its status | Yongkang Dist | Taiwan | Unknown status |
| Smilow Cancer Hospital At Yale Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Renovatio Clinical Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.