649
Participants
Start Date
December 11, 2018
Primary Completion Date
February 28, 2022
Study Completion Date
August 22, 2024
Cisplatin
Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan.
Oxaliplatin
Oxaliplatin 130 mg/m² administered by intravenous infusion every 3 weeks.
Fluorouracil (5-FU)
Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle.
Capecitabine
Capecitabine 1000 mg/m² administered orally twice daily on Days 1-14 of each treatment cycle
Paclitaxel
Paclitaxel 175 mg/m² administered by intravenous infusion every 3 weeks.
Tislelizumab
Tislelizumab 200 mg administered by intravenous infusion every 3 weeks.
Placebo
Placebo to match tislelizumab administered by intravenous infusion every 3 weeks.
Chi Mei Medical Center, Yongkang Dist
Institut Jules Bordet, Anderlecht
Coffs Harbour Base Hospital, Coffs Harbour
University Hospitals Leuven, Leuven
St Vincents Hospital Melbourne, Fitzroy
Chc Montlegia, Liège
Grand Hopital de Charleroi Site Notre Dame, Charleroi
Az Sint Jan Brugge, Bruges
Hospital Clinic de Barcelona, Barcelona
UZ GENT, Ghent
Cha Bundang Medical Center, Cha University, BundangGu SeongnamSi
Seoul National University Bundang Hospital, BundangGu SeongnamSi
Istituto Europeo Di Oncologia, Milan
Universitatsklinikum Hamburg Eppendorf, Hamburg
Gachon University Gil Medical Center, NamdongGu
Chu Besancon Hopital Jean Minjoz, Doubs
Hospital General Universitario Gregorio Maranon, Madrid
Hospital Regional Universitario de Malaga, Málaga
Chru de Brest Hopital Cavale Blanche, Brest
Hospital Universitario Central de Asturias, Oviedo
Chu Bordeaux Hopital Haut Leveque, Pessac
Iov Istituto Oncologico Veneto Irccs, Padua
Keimyung University Dongsan Hospital, Dalseogu
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau, SaintHerblain
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst, Meldola
Hospital Universitario Miguel Servet, Zaragoza
Chonnam National University Hwasun Hospital, HwasunGun
Centre Oscar Lambret, Lille
Azienda Ospedaliera Universitaria Delle Marche, Torrette
Chiayi Chang Gung Memorial Hospital, Chiayi City
Centre Leon Berard, Lyon
Chi Mei Hospital Liouying, Liuying Dist
Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin, Heilbronn
Hopital Saint Antoine Service Dhepato Gastro Enterologie, Paris
Hopital Europeen Georges Pompidou, Paris
Istituto Nazionale Tumori Fondazione G Pascale, Napoli
Chu de Poitiers Site de La Mileterie, Poitiers
Hopital Franco Britannique, LevalloisPerret
Beijing Friendship Hospital, Capital Medical University, Beijing
The Fifth Medical Center of Chinese Pla General Hospital, Beijing
Beijing Cancer Hospital, Beijing
Peking Union Medical College Hospital, Beijing
Liaoning Cancer Hospital and Institute, Shenyang
Harbin Medical University Cancer Hospital, Harbin
Rbih Ivanovo Regional Oncological Dispensary, Ivanovo
Arkhangelsk Regional Clinical Oncological Dispensary, Arkhangelsk
State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary, Kuzmolovsky
Pavlov First Saint Petersburg State Medical University, SaintPetersburg
Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf, SaintPetersburg
Fudan University Shanghai Cancer Center, Shanghai
Sc Centrul de Oncologie Sf Nectarie Srl, Craiova
Jiangsu Province Hospital, Nanjing
The First Peoples Hospital of Changzhou, Changzhou
Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital ), Wuxi
The Affiliated Hospital of Xuzhou Medical University, Xuzhou
Nantong Tumor Hospital Branch North, Nantong
Anhui Provincial Hospital, Hefei
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital, Hefei
The Second Hospital of Anhui Medical University, Hefei
Shandong Cancer Hospital, Jinan
Weifang Peoples Hospital, Weifang
Linyi Cancer Hospital, Linyi
Tianjin Medical University Cancer Institute and Hospital, Tianjin
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
The Second Affiliated Hospital of Nanchang University, Nanchang
Rostov State Medical University, RostovonDon
The First Affiliated Hospital of Fujian Medical University, Fuzhou
Fujian Cancer Hospital, Fuzhou
The First Affiliated Hospital of Xiamen University, Xiamen
Zhongshan Hospital Xiamen University, Xiamen
Quanzhou First Affliated Hospital of Fujian Medical University, Quanzhou
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca, ClujNapoca
Medisprof Cancer Center, ClujNapoca
China Medical University Hospital, North Dist
Radiotherapy Center Cluj, ClujNapoca
Hunan Cancer Hospital, Changsha
Hubei Cancer Hospital, Wuhan
Xiangyang Central Hospital, Xiangyang
Henan Cancer Hospital, Zhengzhou
The First Affiliated Hospital of Zhengzhou University, Zhengzhou
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang
Orenburg Regional Clinical Oncology Center, Orenburg
The First Affiliated Hospital, Sun Yat Sen University, Guangzhou
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou
Guangdong Province Traditional Chinese Medical Hospitsal, Guangzhou
The Sixth Affiliated Hospital, Sun Yat Sen University, Guangzhou
Cancer Hospital of Shantou University Medical College, Shantou
The Tumor Hospital Affiliated to Guangxi Medical University, Nanning
Hainan General Hospital, Haikou
Smilow Cancer Hospital At Yale, New Haven
Renovatio Clinical, The Woodlands
Shanxi Provincial Peoples Hospital, Taiyuan
Fakultni Thomayerova Nemocnice, Prague
Universitares Krebszentrum Leipzig, Leipzig
Akita University Hospital, Akitashi
National Cancer Center Hospital East, Kashiwa
Nho Kyushu Cancer Center, Fukuoka
National Hospital Organization Kyushu Medical Center, Fukuokacity
Hyogo Cancer Center, AkashiShi
Johas Kansai Rosai Hospital, Amagasakishi
Kanagawa Cancer Center, Yokohama
University Hospital, Kyoto Prefectural Univ of Medicine, KyotoShi
Osaka International Cancer Institute, OsakaShi
The University of Osaka Hospital, Suitashi
Saitama Cancer Center, Kitaadachigun
National Cancer Center Hospital, ChuoKu
Hiroshima University Hospital, Hiroshima
Kumamoto University Hospital, Kumamoto
Niigata Cancer Center Hospital, Niigata
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny, Brzozów
Szpital Wojewodzki Im Mikoaja Kopernika W Koszalinie, Koszalin
Spzoz Mswia Z Warminsko Mazurskim Centrum Onkologii, Olsztyn
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy, Warsaw
Smg Snu Boramae Medical Center, DongjakGu
Korea University Guro Hospital, GuroGu
The Catholic University of Korea, Seoul St Marys Hospital, SeochoGu
Samsung Medical Center Hematology Oncology, Seoul
Asan Medical Center, SongpaGu
Hospital Universitario Vall Dhebron, Barcelona
Institut Catala Doncologia, Barcelona
The Christie Hospital, Greater Manchester
Guys and St Thomas Hospital Nhs Foundation Trust, London
Lead Sponsor
BeiGene
INDUSTRY