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Brief Title: A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official Title: A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Study ID: NCT03783442
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Smilow Cancer Hospital at Yale-New Haven - Neurology, New Haven, Connecticut, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Allegheny General Hospital (AGH), Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina, United States
University of Texas Health Science Center of San Antonio, San Antonio, Texas, United States
Renovatio Clinical, The Woodlands, Texas, United States
Coffs Harbour Hospital, Coffs Harbour, Pacific Highway, Australia
Townsville Hospital, Douglas, Queensland, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
St Vincent's Hospital, Fitzroy, Victoria, Australia
Ballarat Oncology & Haematology Services, Wendouree, Victoria, Australia
Antwerp University Hospital, Edegem, Antwerpen, Belgium
Institut Jules Bordet - Oncologie Médicale, Anderlecht, Brussels Capital Region, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame, Charleroi, Hainaut, Belgium
UZ Gent - Radiologie, Gent, Oost-Vlaanderen, Belgium
UZ Leuven - Campus Gasthuisberg, Leuven, Vlaams Brabant, Belgium
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology, Brugge, West-Vlaanderen, Belgium
CHC Mont Legia, Liège, , Belgium
CHU Liège Sart Tilman, Liège, , Belgium
Anhui Provincial Cancer Hospital, Hefei, Anhui, China
Anhui Medical University - The Second Hospital, Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Beijing Friendship Hospital - Oncology, Beijing, Beijing, China
The Fifth Medical Center of Chinese PLA General Hospital, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital - Oncology, Beijing, Beijing, China
Fujian Provincial Cancer Hospital - Oncology, Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China
Zhongshan Hospital Xiamen University, Xiamen, Fujian, China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospital, Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College, Shantou, Guangdong, China
Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China
Hainan General Hospital - Oncology, Haikou, Hainan, China
Affiliated Tumor Hospital of Harbin Medical University, Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University - Oncology, Henan, Henan, China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Henan Cancer Hospital - Oncology, Zhengzhou, Henan, China
Hubei Cancer Hospital - Oncology, Wuhan, Hubei, China
Xiangyang Central Hospital, Xiangyang, Hubei, China
Hunan Cancer Hospital - GCP Office, Changsha, Hunan, China
The First People's Hospital of Changzhou - Oncology, Changzhou, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
Nantong Cancer Hospital, Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University - Radiology, Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute - Medical Oncology - Oncology, Shenyang, Liaoning, China
Quanzhou First Hospital - Radiotherapy/Nuclear Medicine, Quanzhou, Quanzhou, China
Shandong Cancer Hospital and Institute, Shandong First Medical University, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
WeiFang People's Hospital, Weifang, Shandong, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanxi Provincial People's Hospital, Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Anhui Provincial Hospital - Oncology, Hefei, , China
The First Affiliated Hospital of Xiamen University - Oncology, Xiamen, , China
Fakultní Nemocnice Olomouc, Olomouc, , Czechia
Thomayerova nemocnice, Praha 4, , Czechia
Nemocnice Na Bulovce, Praha 8, , Czechia
Hôpital Morvan - CHRU de Brest - cancérologie et d'hématologie, Brest Cedex, Bretagne, France
CHRU de Besançon- Hôpital Jean Minjoz, Besançon Cedex, Doubs, France
CHU Bordeaux Hôpital Du Haut-Lévêque, Pessac Cedex, Gironde, France
Institut Hospitalier Franco-Britannique (IHFB) - Levallois-Perret - 4 Rue Kleber, Levallois-Perret, Hauts-de-Seine, France
ICO, Saint-Herblain, Loire-Atlantique, France
Center Oscar Lambret - Alliance Member, Lille, Nord, France
Hopital Saint-Antoine / Service d'Hepato-Gastro-Enterologie, Paris Cedex 12, Paris, France
Centre Léon Bérard, Lyon, Rhône, France
Centre Hospitalier Universitaire de Poitiers, Poitiers, Vienne, France
Hopital Europeen Georges Pompidou - Digestive Oncology, Paris, , France
Groupe Hospitalier Paris Saint Joseph - Oncologie, Paris, , France
SLK Kliniken Heilbronn GmbH - Klinik für Radiologie, Minimalinvasive Therapien und Nuklearmedizin, Heilbronn, Baden-Württemberg, Germany
University Hospital Tuebingen, Tuebingen, Baden-Württemberg, Germany
Johannes Wesling Klinikum Minden, Minden, Nordrhein-Westfalen, Germany
Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany
University Hospital Of Leipzig, Leipzig, Sachsen, Germany
University Hospital Hamburg- Eppendorf, Hamburg, , Germany
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica, Torino, Ancona, Italy
Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori', IRCCS - Laboratorio, Meldola, Emilia-Romagna, Italy
Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc - Oncologia Medica, Ancona, , Italy
Ieo, Irccs, Milano, , Italy
Asst Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori, Napoli, , Italy
Istituto Oncologico Veneto IOV-IRCCS, Padova, , Italy
SO S.Chiara, AOU Pisana - Oncologia 2, Pisa, , Italy
National Cancer Center Hospital East - Gastrointestinal Oncology, Kashiwa, Chiba, Japan
Kyushu Medical Center - Gastroenterological Surgery, Fukuoka, Hukuoka, Japan
National Hospital Organization Kyushu Cancer Center - GI and Medical Oncology, Fukuoka, Hukuoka, Japan
Kobe City Medical Center General Hospital - Medical Oncology, Kobe, Hyogo, Japan
Kagawa University Hospital - Oncology, Kita-gun, Kagawa, Japan
Kanagawa Cancer Center - Gastroenterological surgery, Yokohama, Kanagawa, Japan
University Hospital, Kyoto Prefectural Univ of Medicine - Gastroenterology, Kamigyō-ku, Kyoto, Japan
Kindai University Nara Hospital, Ikoma, Osaka, Japan
Osaka University Hospital - Medical Oncology, Suita, Osaka, Japan
National Cancer Center Hospital - Gastrointestinal Oncology, Chuo Ku, Tokyo, Japan
Hyogo Cancer Center, Akashi, , Japan
Akita University Hospital - Pediatrics, Akita-shi, , Japan
Kansai Rosai Hospital - Gastroenterological Surgery, Amagasaki, , Japan
Hiroshima University Hospital - Gastrointestinal Surgery, Hiroshima, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka International Cancer Institute - Clinical Oncology, Osaka, , Japan
Saitama Cancer Center - Gastroenterology, Saitama, , Japan
Seoul National University Bundang Hospital - Hematology/Oncology, Seongnam-si, Gyeonggido [Kyonggi-do], Korea, Republic of
CHA Bundang Medical Center, CHA University - Oncology, Seongnam-si, Gyeonggido, Korea, Republic of
Gachon University Gil Medical Center - Oncology, Incheon, Incheon Gwang'yeogsi [Inch'n-K, Korea, Republic of
Chonnam National University Hwasun Hospital - Hematology and Oncology Clinic, Hwasun, Jeonranamdo [Chollanam-do], Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea, Republic of
Samsung Medical Center - Hematology-Oncology, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
SMG-SNU Boramae Medical Center - Oncology, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Korea University Guro Hospital - Hematology-Oncology, Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, Mazowieckie, Poland
Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi, Brzozow, Podkarpackie, Poland
Szpital Wojewodzki w Koszalinie, Koszalin, Pomorskie, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii, Olsztyn, Warminsko-mazurskie, Poland
Clinical Research Center Sp. z o.o., Medic-R Sp. K., Poznan, Wielkopolskie, Poland
Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca, Cluj-Napoca, Cluj, Romania
Radiotherapy Center Cluj, Floreşti, Cluj, Romania
Centrul de Oncologie Sf. Nectarie, Craiova, Dolj, Romania
Institutul Clinic Fundeni, Bucuresti, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Medisprof, Cluj-Napoca, , Romania
Centrul de Oncologie Euroclinic, Iaşi, , Romania
Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation
Leningrad Regional Oncology Dispensary, Kuz'molovskiy, Leningradskaya Oblast, Russian Federation
Orenburg Regional Clinical Oncology Center, Orenburg, Orenburgskaya Oblast, Russian Federation
Rostov Research Institute of Oncology (RRIO), Rostov-Na-Donu, Rostovskaya Oblast, Russian Federation
The First Saint-Petersburg State Medical University named after Academician I.P. Pavlov, Saint Petersburg, Sankt-Peterburg, Russian Federation
City Oncology Dispensary, Saint Petersburg, Sankt-Peterburg, Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Petrov Research Institute of Oncology, Saint Petersburg, , Russian Federation
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Institut Catalá d´Oncología (I.C.O.), L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Madrid Norte Sanchinarro, Sanchinarro, Madrid, Spain
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
H.U.V.Arrixaca, Murcia, , Spain
Hospital Universitario Virgen De La Victoria, Málaga, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Kaohsiung Veterans General Hospital - Thoracic Surgery, Kaohsiung, , Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology, Kaohsiung, , Taiwan
China Medical University Hospital - Oncology - Taichung, Taichung, , Taiwan
Chi Mei Medical Center - YongKang - Chi Mei Medical Center, Tainan, , Taiwan
Chi Mei Hospital, Liouying - Department of Oncology, Tainan, , Taiwan
Guys and St Thomas' Hospital, London, City Of London, United Kingdom
Royal Marsden NHS Foundation Trust Sutton, London, City Of London, United Kingdom
The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital, London, City Of London, United Kingdom
Mount Vernon Cancer Centre, Northwood, England, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre, Maidstone, Kent, United Kingdom
Beatson West of Scotland Cancer Centre - Oncology, Glasgow, Scotland, United Kingdom
The Christie NHS Foundation Trust - Oak Road Treatment Centr, Manchester, , United Kingdom
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR