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
Who is this study for? Patients with Esophageal Cancer
What treatments are being studied? Tislelizumab
Status: Completed
Location: See all (123) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Connecticut
Smilow Cancer Hospital At Yale
New Haven
Texas
Renovatio Clinical
The Woodlands
Other Locations
Australia
Coffs Harbour Base Hospital
Coffs Harbour
St Vincents Hospital Melbourne
Fitzroy
Belgium
Institut Jules Bordet
Anderlecht
Az Sint Jan Brugge
Brugge
Grand Hopital de Charleroi Site Notre Dame
Charleroi
UZ GENT
Gent
University Hospitals Leuven
Leuven
Chc Montlegia
Liege
China
Beijing Cancer Hospital
Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing
Peking Union Medical College Hospital
Beijing
The Fifth Medical Center of Chinese Pla General Hospital
Beijing
Hunan Cancer Hospital
Changsha
The First Peoples Hospital of Changzhou
Changzhou
Fujian Cancer Hospital
Fuzhou
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Guangdong Province Traditional Chinese Medical Hospitsal
Guangzhou
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou
The Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou
Hainan General Hospital
Haikou
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang Cancer Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei
Anhui Provincial Hospital
Hefei
The Second Hospital of Anhui Medical University
Hefei
Shandong Cancer Hospital
Jinan
Linyi Cancer Hospital
Linyi
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Province Hospital
Nanjing
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning
Nantong Tumor Hospital Branch North
Nantong
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou
Fudan University Shanghai Cancer Center
Shanghai
Cancer Hospital of Shantou University Medical College
Shantou
Liaoning Cancer Hospital and Institute
Shenyang
Shanxi Provincial Peoples Hospital
Taiyuan
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Weifang Peoples Hospital
Weifang
Hubei Cancer Hospital
Wuhan
Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital )
Wuxi
The First Affiliated Hospital of Xiamen University
Xiamen
Zhongshan Hospital Xiamen University
Xiamen
Xiangyang Central Hospital
Xiangyang
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Henan Cancer Hospital
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
France
Chru de Brest Hospital Morvan
Brest
Chu Besancon Hopital Jean Minjoz
Doubs
Hopital Franco Britannique
Levalloisperret
Centre Oscar Lambret
Lille
Centre Leon Berard
Lyon Cedex
Hopital Europeen Georges Pompidou
Paris
Hopital Saint Antoine Service Dhepato Gastro Enterologie
Paris Cedex
Chu Bordeaux Hopital Haut Leveque
Pessac
Chu de Poitiers Site de La Mileterie
Poitiers
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
Saintherblain
Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg
Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin
Heilbronn
Universitares Krebszentrum Leipzig
Leipzig
Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola
Istituto Europeo Di Oncologia
Milano
Istituto Nazionale Tumori Fondazione G Pascale
Napoli
Iov Istituto Oncologico Veneto Irccs
Padova
Azienda Ospedaliera Universitaria Delle Marche
Torrette
Japan
Hyogo Cancer Center
Akashi
Akita University Hospital
Akitashi
Johas Kansai Rosai Hospital
Amagasakishi
National Cancer Center Hospital
Chuoku
National Hospital Organization Kyushu Medical Center
Fukuokacity
Nho Kyushu Cancer Center
Fukuokashi
Hiroshima University Hospital
Hiroshima
National Cancer Center Hospital East
Kashiwa
Saitama Cancer Center
Kitaadachigun
Kumamoto University Hospital
Kumamoto
University Hospital, Kyoto Prefectural Univ of Medicine
Kyoto
Niigata Cancer Center Hospital
Niigata
Osaka International Cancer Institute
Osakashi
Osaka University Hospital
Suitashi
Kanagawa Cancer Center
Yokohamashi
Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozow
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
Warszawa
Republic of Korea
Keimyung University Dongsan Hospital
Dalseogu
Cha Bundang Medical Center, Cha University
Gyeonggido
Chonnam National University Hwasun Hospital
Hwasungun
Gachon University Gil Medical Center
Incheon
Seoul National University Bundang Hospital
Seongnamsi
Asan Medical Center
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center Hematology Oncology
Seoul
Smg Snu Boramae Medical Center
Seoul
The Catholic University of Korea, Seoul St Marys Hospital
Seoul
Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
Clujnapoca
Medisprof Cancer Center
Clujnapoca
Radiotherapy Center Cluj
Clujnapoca
Sc Centrul de Oncologie Sf Nectarie Srl
Craiova
Russian Federation
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk
Rbih Ivanovo Regional Oncological Dispensary
Ivanovo
State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary
Kuzmolovsky
Orenburg Regional Clinical Oncology Center
Orenburg
Rostov State Medical University
Rostovnadonu
Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf
Saintpetersburg
Pavlov First Saint Petersburg State Medical University
Saintpetersburg
Spain
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario Vall Dhebron
Barcelona
Institut Catala Doncologia
Barcelona
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Regional Universitario de Malaga
Malaga
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario Miguel Servet
Zaragoza
Taiwan
Chiayi Chang Gung Memorial Hospital
Chiayi
China Medical University Hospital
Taichung
Chi Mei Hospital Liouying
Tainan
Chi Mei Medical Center
Tainan
United Kingdom
The Christie Hospital
Greater Manchester
Guys and St Thomas Hospital Nhs Foundation Trust
London
Time Frame
Start Date: 2018-12-11
Completion Date: 2024-08-22
Participants
Target number of participants: 649
Treatments
Experimental: Tislelizumab + Chemotherapy
Tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each cycle every 3 weeks (Q3W) plus one of the following until unacceptable toxicity, disease progression or withdrawal for other reasons; each cycle is 21 days~* Chemotherapy Doublet A: cisplatin 60-80 mg/m\^2 or oxaliplatin 130 mg/m\^2 administered IV on Day 1 of each cycle Q3W and 5-fluorouracil IV 750-800 mg/m\^2 on Days 1 to 5 of each cycle Q3W;~* Chemotherapy Doublet B: cisplatin 60-80 mg/m\^2 or oxaliplatin 130 mg/m\^2 administered IV on Day 1 of each cycle Q3W and capecitabine orally 1000 mg/m\^2 on Days 1 to 14 of each cycle, twice a day; or~* Chemotherapy Doublet C: cisplatin 60-80 mg/m\^2 administered IV on Day 1 or 2 or oxaliplatin 130 mg/m\^2 administered IV on Day 1 of each cycle Q3W and paclitaxel 175 mg/m\^2 IV on Day 1 of each cycle Q3W; cisplatin may be given in 3 divided doses on Days 1, 2, and 3 depending on local guidelines
Active_comparator: Placebo + Chemotherapy
Matched placebo administered IV on Day 1 of each cycle every 3 weeks (Q3W) plus one of the following until unacceptable toxicity, disease progression or withdrawal for other reasons; each cycle is 21 days~* Chemotherapy Doublet A: cisplatin 60-80 mg/m\^2 or oxaliplatin 130 mg/m\^2 administered IV on Day 1 of each cycle Q3W and 5-fluorouracil IV 750-800 mg/m\^2 on Days 1 to 5 of each cycle Q3W;~* Chemotherapy Doublet B: cisplatin 60-80 mg/m\^2 or oxaliplatin 130 mg/m\^2 administered IV on Day 1 of each cycle Q3W and capecitabine orally 1000 mg/m\^2 on Days 1 to 14 of each cycle, twice a day; or~Chemotherapy Doublet C: cisplatin 60-80 mg/m\^2 administered IV on Day 1 or 2 or oxaliplatin 130 mg/m\^2 administered IV on Day 1 of each cycle Q3W and paclitaxel 175 mg/m\^2 IV on Day 1 of each cycle Q3W; cisplatin may be given in 3 divided doses on Days 1, 2, and 3 depending on local guidelines
Authors
Feng 峰 Ye 叶, Daniel Reuben, Eric Raymond, Moses Raj, Lin Shen, Eric Terrebonne, Kai Wille, Markus Moehler, Carsten Bokemeyer, Daniel Swinson, Florian Lordick, Karen Briscoe, Aziz Zaanan, Richard Hubner, Benoist Chibaudel, David Tougeron, Justin Waters, Michael Bitzer, Jill Lacy, Laura Tenner, Amelie Deleporte, Hongbing Duan, Alain Bols, Jeff Evans, Ghislain Houbiers, Libero Ciuffreda, Constantin Volovat, Nina Karaseva, Monica Lencioni, Javier Carrasco, Satoru Motoyama, Yongqiang Li, Atsushi 淳 Takeno 竹野, Sang-Hee Cho, Satoru 悟 Nakagawa 中川, Feng Ye, Jean-Philippe Metges, Sue-Anne McLachlan, Xinmin Yu, Ilya Anatolievich Pokataev, Catherine Loly, Antonio Cubillo Gracián, Karen Geboes, Tamara Sauri, Yongqian Shu, Antonio Avallone, Yifu He, Uwe Martens, George Kannourakis, Marc Peeters, Nicola Fazio, Yueyin Pan, Taroh Satoh, Yuxian Bai, Eric Van Cutsem, Giovanni Luca Frassineti, Rossana Berardi, Ryu 立 Ishihara 石原, Francesca Bergamo, Ken 健 Kato 加藤, Takeshi 剛 Ishikawa 石川, Bohuslav Melichar, Salvatore Siena, Christelle De la Fouchardiere, Yoshihiro Kakeji, Michael Schenker, Manabu 学 Muto 武藤, Lucjan Wyrwicz
Related Therapeutic Areas
Sponsors
Leads: BeiGene