A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
NCT ID: NCT03783442
Last Updated: 2025-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
649 participants
INTERVENTIONAL
2018-12-11
2024-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tislelizumab + Chemotherapy
Participants received tislelizumab 200 milligrams (mg) administered intravenously (IV) on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).
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 + Chemotherapy
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Chemotherapy options were a platinum agent (cisplatin 60-80 mg/m² intravenously on Day 1 or oxaliplatin 130 mg/m² intravenously on Day 1) combined with a fluoropyrimidine (fluorouracil \[750-800 mg/m² intravenously on Days 1-5\] or capecitabine \[1000 mg/m² orally twice daily on Days 1-14\]) or paclitaxel (175 mg/m² intravenously on Day 1).
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.
Placebo
Placebo to match tislelizumab administered by intravenous infusion every 3 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
2. Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
3. Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
4. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
5. 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)
6. Evidence of complete esophageal obstruction not amenable to treatment
7. Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) \< 83.5 per investigator's choice
8. Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
9. 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)
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Smilow Cancer Hospital At Yale
New Haven, Connecticut, United States
Renovatio Clinical
The Woodlands, Texas, United States
Coffs Harbour Base Hospital
Coffs Harbour, New South Wales, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Institut Jules Bordet
Anderlecht, , Belgium
Az Sint Jan Brugge
Bruges, , Belgium
Grand Hopital de Charleroi Site Notre Dame
Charleroi, , Belgium
UZ GENT
Ghent, , Belgium
University Hospitals Leuven
Leuven, , Belgium
Chc Montlegia
Liège, , Belgium
Anhui Provincial Hospital
Hefei, Anhui, China
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Fifth Medical Center of Chinese Pla General Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Quanzhou First Affliated Hospital of Fujian Medical University
Quanzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospitsal
Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Hainan General Hospital
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital Branch North
Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University North Campus (Wuxi Fourth Peoples Hospital )
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial Peoples Hospital
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Fakultni Thomayerova Nemocnice
Prague, , Czechia
Chru de Brest Hopital Cavale Blanche
Brest, , France
Chu Besancon Hopital Jean Minjoz
Doubs, , France
Hopital Franco Britannique
LevalloisPerret, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital Saint Antoine Service Dhepato Gastro Enterologie
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Chu Bordeaux Hopital Haut Leveque
Pessac, , France
Chu de Poitiers Site de La Mileterie
Poitiers, , France
Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
SaintHerblain, , France
Universitatsklinikum Hamburg Eppendorf
Hamburg, , Germany
Slk Kliniken Heilbronn Gmbh Klinik Fur Radiologie, Minimalinvasive Therapien Und Nuklearmedizin
Heilbronn, , Germany
Universitares Krebszentrum Leipzig
Leipzig, , Germany
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Istituto Nazionale Tumori Fondazione G Pascale
Napoli, , Italy
Iov Istituto Oncologico Veneto Irccs
Padua, , Italy
Azienda Ospedaliera Universitaria Delle Marche
Torrette, , Italy
Akita University Hospital
Akitashi, Akita, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Nho Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
Fukuokacity, Fukuoka, Japan
Hyogo Cancer Center
AkashiShi, Hyōgo, Japan
Johas Kansai Rosai Hospital
Amagasakishi, Hyōgo, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
University Hospital, Kyoto Prefectural Univ of Medicine
KyotoShi, Kyoto, Japan
Osaka International Cancer Institute
OsakaShi, Osaka, Japan
The University of Osaka Hospital
Suitashi, Osaka, Japan
Saitama Cancer Center
Kitaadachigun, Saitama, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, , Poland
Szpital Wojewodzki Im Mikoaja Kopernika W Koszalinie
Koszalin, , Poland
Spzoz Mswia Z Warminsko Mazurskim Centrum Onkologii
Olsztyn, , Poland
Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
Warsaw, , Poland
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, , Romania
Medisprof Cancer Center
ClujNapoca, , Romania
Radiotherapy Center Cluj
ClujNapoca, , Romania
Sc Centrul de Oncologie Sf Nectarie Srl
Craiova, , Romania
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk, Arkhangelskaya oblast, Russia
Rbih Ivanovo Regional Oncological Dispensary
Ivanovo, Ivanovo Oblast, Russia
State Budget Healthcare Institution Leningrad Regional Clinical Oncologic Dispensary
Kuzmolovsky, Leningradskaya Oblast', Russia
Orenburg Regional Clinical Oncology Center
Orenburg, Orenburg Oblast, Russia
Rostov State Medical University
RostovonDon, Rostov Oblast, Russia
Pavlov First Saint Petersburg State Medical University
SaintPetersburg, Sankt-Peterburg, Russia
Fsbi National Medical Research Center For Oncology Na Nn Petrov of the Moh of the Rf
SaintPetersburg, , Russia
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, South Korea
Cha Bundang Medical Center, Cha University
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
NamdongGu, Incheon Gwang'yeogsi, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, South Korea
Smg Snu Boramae Medical Center
DongjakGu, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital
GuroGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Samsung Medical Center Hematology Oncology
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario Vall Dhebron
Barcelona, , Spain
Institut Catala Doncologia
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Chiayi Chang Gung Memorial Hospital
Chiayi City, , Taiwan
Chi Mei Hospital Liouying
Liuying Dist, , Taiwan
China Medical University Hospital
North Dist, , Taiwan
Chi Mei Medical Center
Yongkang Dist, , Taiwan
The Christie Hospital
Greater Manchester, , United Kingdom
Guys and St Thomas Hospital Nhs Foundation Trust
London, , United Kingdom
Countries
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References
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Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17.
Xu J, Kato K, Hubner R, Park SR, Kojima T, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Wu H, Wang L, Yan S, Shi J, Kadva A, Yoon HH. First-Line Tislelizumab Plus Chemotherapy for Esophageal Squamous Cell Carcinoma with Programmed Death-Ligand 1 Expression >/= 1%: A Retrospective Analysis of RATIONALE-306. Adv Ther. 2025 May;42(5):2269-2284. doi: 10.1007/s12325-025-03115-9. Epub 2025 Mar 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-000587-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20181013
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-194741
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-306
Identifier Type: -
Identifier Source: org_study_id
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