A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

Study Overview

• Status: Completed
• Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
• Intervention / Treatment: Drug: Tislelizumab; Drug: Irinotecan; Drug: Paclitaxel; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 512
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • UZ Antwerpen
  • Antwerp, Belgium, 2600
    • Imelda Ziekenhuis
  • Brussels, Belgium, 1000
    • Cliniques Universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • University Hospitals Leuven
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman
• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Anhui Medical University - The Second Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer Hospital
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
    • Xiamen, Fujian, China, 361004
      • The First Affiliated hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • The Sixth Affiliated Hospital of Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • The First Hospital, Sun Yat-sen University
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College
    • Shenzhen, Guangdong, China, 518035
      • Peking University Shenzhen Hospital
  • Hebei
    • Baoding, Hebei, China, 71000
      • Affiliated Hospital of Hebei University
    • Shijiazhuang, Hebei, China, 050011
      • Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Xinxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 400037
      • Hubei Cancer Hospital
    • Xiangyang, Hubei, China, 441000
      • Xiangyang Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • The First People's Hospital of Changzhou
    • Huai'an, Jiangsu, China, 223002
      • Huai'an Second People's Hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 21008
      • Nanjing Drum Tower Hospital
    • Nantong, Jiangsu, China, 226000
      • Nantong Tumor Hospital
    • Xuzhou, Jiangsu, China, 221002
      • The Affiliated Hospital Of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Jiangxi Cancer Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jinlin University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
    • Linyi, Shandong, China, 371300
      • Shandong Linyi Tumor Hospital
    • Weifang, Shandong, China, 261000
      • Weifang People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan Cancer Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 140100
      • Shanxi Provincial People's Hospital
    • Xi'an, Shanxi, China, 710014
      • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
  • Sichuan
    • Chengdu, Sichuan, China, 610071
      • Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Yunnan Cancer Hospital - Oncology
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310006
      • Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China, 310006
      • The first affiliated hospital, Zhejiang university
• France
  • Besançon, France, 25000
    • CHRU Besançon
  • Brest, France, 29200
    • CHRU de Brest Hôpital Morvan
  • Dijon, France, 21079
    • Centre Georges-Francois Leclerc
  • Lille, France, 59000
    • Center Oscar Lambret - Alliance Member
  • Lyon, France, 69008
    • Hopital Prive Jean Mermoz
  • Montpellier, France, 34298
    • ICM Val d'Aurelle
  • Paris, France, 94805
    • Comprehensive Cancer Center-Gustave Roussy
  • Pessac, France, 33604
    • Hôpital Haut-Lévèque
  • Poitiers, France, 86021
    • Chu de Poitiers
  • Saint-Herblain, France, 44805
    • Centre de Lutte Contre le Cancer
  • Strasbourg, France, 67000
    • Clinique Sainte-Anne
• Germany
  • Berlin, Germany, 13353
    • Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 20249
    • Hamatologisch-Onkologische Praxis Eppendorf (HOPE)
  • Koln, Germany, 50937
    • Universitatsklinikum Koln, Innere Medizin I
  • Leipzig, Germany, 04103
    • Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz
  • Mannheim, Germany, 68167
    • Universitaetsmedizin Mannheim, II. Medizinische Klinik
  • Weiden, Germany, 92637
    • Kliniken Nordoberpfalz, Klinikum Weiden
• Italy
  • Catania, Italy, 95122
    • PO Garibaldi-Nesima, ARNAS Garibaldi
  • Faenza, Italy, 48018
    • AUSL della Romagna, Osp. degli Infermi
  • Meldola, Italy, 47014
    • IRCCS IRST
  • Naples, Italy, 80131
    • AOU - Seconda Università degli Studi di Napoli
  • Orbassano, Italy, 10043
    • AOU San Luigi di Orbassano
  • Piacenza, Italy, 29121
    • Ospedale Guglielmo da Saliceto, AUSL Piacenza
  • Pisa, Italy, 56126
    • A.O.U. Pisana, Stabilimento di Santa Chiara
  • Torino, Italy, 10126
    • AO Citta della Salute e della Scienza di Torino - Presidio O
• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Fukuoka, Japan, 811-1395
    • National Kyushu Cancer Center
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Kagawa, Japan, 761-0793
    • Kagawa University Hospital
  • Kochi, Japan, 781-8555
    • Kochi Health Sciences Center
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Osaka, Japan, 569-8686
    • Osaka Medical College Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 100-0045
      • National Cancer Center Hospital East
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
      • Shikoku Cancer Center
  • Hyogo
    • Akashi, Hyogo, Japan, 673-8558
      • Hyogo Cancer Center
    • Kobe, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna University School of Medicine Hospital
  • Nara
    • Ikoma, Nara, Japan, 630-0293
      • Kindai University Nara Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Saitama
    • Ina, Saitama, Japan, 362-0806
      • Saitama Cancer Center
  • Shizuoka
    • Nagaizumi, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-Ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of JFCR
• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seongnam-si, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 6351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 8308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 5505
    • Asan Medical Center - Oncology
  • Seoul, Korea, Republic of, 58128
    • Chonnam National University Hwasun Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28009
    • Hospital Universitario Gregorio Marañón
  • Madrid, Spain, 08908
    • Institut Catala d'Oncologia
  • Madrid, Spain, 28006
    • Hospital Madrid Norte Sanchinarro
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de La Arrixaca
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Madrid
    • Barcelona, Madrid, Spain, 08003
      • Hospital Del Mar
• Taiwan
  • Kaohsiung, Taiwan, 833
    • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 710
    • Chi Mei Medical Center
  • Tainan, Taiwan, 73657
    • Chi Mei Hospital, Liouying
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • NAP
    • Changhua, NAP, Taiwan, 500-06
      • Changhua Christian Hospital
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, SE1 9RT
    • Guys & St. Thomas Hospital
  • London, United Kingdom, SW17 0RE
    • St. George's Hospital
  • London, United Kingdom, W12 0HS
    • Imperial NHS Trust
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute-London
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Northwood, United Kingdom, HA6 2RN
    • Mount Vernon Cancer Centre
  • Sutton, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust - Haemato-Oncology
  • Wolverhampton, United Kingdom, WV10 0QP
    • New Cross Hospital
• United States
  • California
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare
    • Los Angeles, California, United States, 90089-0112
      • University of Southern California Norris Comprehensive Cancer Center
  • Illinois
    • Warrenville, Illinois, United States, 60555
      • Northwestern Medicine Cancer Center Warrenville
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Ohio
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic Cancer Center
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • San Antonio Military Medical Center
    • Houston, Texas, United States, 77090
      • Millennium Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
3. At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Key Exclusion Criteria:

1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
3. Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
5. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
7. Active brain or leptomeningeal metastasis.
8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
10. Known history of Human Immunodeficiency Virus (HIV)
11. Has cardiovascular risk factors
12. Pregnant or breastfeeding woman.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab; Tislelizumab on Day 1, given every 21 days	Drug: Tislelizumab; 200 mg administered intravenously (IV); Other Names: BGB-A317
Active Comparator: Investigator chosen chemotherapy (ICC); Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days	Drug: Irinotecan; 125 mg/m^2 administered IV; Drug: Paclitaxel; 135-175 mg /m² administered IV , or 80-100 mg/m^2 administered IV according to local guidelines for standard of care; Drug: Docetaxel; 75 mg/m^2 administered IV or 70 mg/m^2 IV in Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set	OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants	Approximately 2 years and 10 months from date of first randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) in the PDL-1 Positive Analysis Set	OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Objective Response Rate (ORR) in the ITT Analysis Set	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets	ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Progression-free Survival (PFS) in the ITT Analysis Set	PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set	PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Duration of Response (DOR) in the ITT Analysis Set	DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.	DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first	Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set	Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes	Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set	Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes	Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set	Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.	Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.	Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.	Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set	Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.	Baseline to Cycle 6 (21 days per cycle)
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set	Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.	Baseline to Cycle 6 (21 days per cycle)
Number of Participants Experiencing Adverse Events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs	From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Virginia Paton, Pharm.D., BeiGene

Publications and helpful links

General Publications

• Van Cutsem E, Kato K, Ajani J, Shen L, Xia T, Ding N, Zhan L, Barnes G, Kim SB. Tislelizumab versus chemotherapy as second-line treatment of advanced or metastatic esophageal squamous cell carcinoma (RATIONALE 302): impact on health-related quality of life. ESMO Open. 2022 Aug;7(4):100517. doi: 10.1016/j.esmoop.2022.100517. Epub 2022 Jul 1.
• Shen L, Kato K, Kim SB, Ajani JA, Zhao K, He Z, Yu X, Shu Y, Luo Q, Wang J, Chen Z, Niu Z, Zhang L, Yi T, Sun JM, Chen J, Yu G, Lin CY, Hara H, Bi Q, Satoh T, Pazo-Cid R, Arkenau HT, Borg C, Lordick F, Li L, Ding N, Tao A, Shi J, Van Cutsem E; RATIONALE-302 Investigators. Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study. J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 28, 2022

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy; paclitaxel; Unresectable; irinotecan; metastatic; docetaxel; esophagus; squamous; second-line
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Topoisomerase I Inhibitors; Docetaxel; Paclitaxel; Irinotecan; Tislelizumab
• Other Study ID Numbers: BGB-A317-302; 2017-003699-30 (EudraCT Number); CTR20171026 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No