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

Primary Purpose

Esophageal Squamous Cell Carcinoma (ESCC)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Paclitaxel
Docetaxel
Irinotecan
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma (ESCC) focused on measuring Unresectable, metastatic, second-line, squamous, esophagus, chemotherapy, paclitaxel, docetaxel, irinotecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 RECIST v1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
  5. Adequate End organ function

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. Apparent 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 PD-1 or 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.

Sites / Locations

  • St. Joseph Heritage Healthcare
  • University of Southern California Norris Comprehensive Cancer Center
  • Northwestern Medicine Cancer Center Warrenville
  • Henry Ford Hospital
  • Toledo Clinic Cancer Center
  • San Antonio Military Medical Center
  • Millennium Oncology
  • Imelda Ziekenhuis
  • UZ Antwerpen
  • Cliniques universitaires Saint-Luc
  • University Hospitals Leuven
  • Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman
  • Anhui Medical University - The Second Hospital
  • Beijing Friendship Hospital
  • Beijing Cancer Hospital
  • Peking Union Medical College Hospital
  • Fujian Medical University Union Hospital
  • The First Affiliated Hospital of Fujian Medical University
  • Fujian Provincial Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • The First Hospital, Sun Yat-sen University
  • The Sixth Affiliated Hospital of Sun Yat-sen University
  • Cancer Hospital of Shantou University Medical College
  • Peking University Shenzhen Hospital
  • Affiliated Hospital of Hebei University
  • Fourth Hospital of Hebei Medical University
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Xinxiang Medical University
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Hubei Cancer Hospital
  • Xiangyang Central Hospital
  • Hunan Cancer Hospital
  • The First People's Hospital Of Changzhou
  • Huai'an Second People's Hospital
  • Jiangsu Province Hospital
  • Nanjing Drum Tower Hospital
  • Nantong Tumor Hospital
  • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi Cancer Hospital
  • The First Hospital of Jinlin University
  • Shandong Cancer Hospital
  • Shandong Linyi Tumor Hospital
  • WeiFang People's Hospital
  • Fudan Cancer Hospital
  • Shanxi Provincial People's Hospital
  • The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)
  • Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital
  • Yunnan Cancer Hospital - Oncology
  • Hangzhou First People's Hospital
  • The First Affiliated Hospital, Zhejiang University
  • Zhejiang Cancer Hospital
  • CHRU Besançon
  • CHRU de Brest Hôpital Morvan
  • Centre Georges-Francois Leclerc
  • Center Oscar Lambret - Alliance Member
  • Hopital Prive Jean Mermoz
  • ICM Val d'Aurelle
  • Comprehensive Cancer Center-Gustave Roussy
  • Hôpital Haut-Lévêque
  • CHU de Poitiers
  • Centre de Lutte Contre le Cancer
  • Clinique Sainte-Anne
  • Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)
  • Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik
  • Hamatologisch-Onkologische Praxis Eppendorf (HOPE)
  • Asklepios Klinik Altona
  • Universitatsklinikum Koln, Innere Medizin I
  • Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)
  • Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz
  • Universitaetsmedizin Mannheim, II. Medizinische Klinik
  • Kliniken Nordoberpfalz, Klinikum Weiden
  • PO Garibaldi-Nesima, ARNAS Garibaldi
  • AUSL della Romagna, Osp. degli Infermi
  • Irccs Irst
  • AOU - Seconda Università degli Studi di Napoli
  • AOU San Luigi di Orbassano
  • Ospedale Guglielmo da Saliceto, AUSL Piacenza
  • A.O.U. Pisana, Stabilimento di Santa Chiara
  • AO Citta della Salute e della Scienza di Torino - Presidio O
  • National Cancer Center Hospital East
  • Shikoku Cancer Center
  • Hyogo Cancer Center
  • Kobe City Medical Center General Hospital
  • St. Marianna University School of Medicine Hospital
  • Kindai University Nara Hospital
  • Osaka University Hospital
  • Saitama Cancer Center
  • Shizuoka Cancer Center
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Akita University Hospital
  • Chiba Cancer Center
  • National Kyushu Cancer Center
  • Hiroshima University Hospital
  • Kagawa University Hospital
  • Kochi Health Sciences Center
  • Kyoto University Hospital
  • Osaka International Cancer Institute
  • Osaka Medical College Hospital
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Asan Medical Center - Oncology
  • Chonnam National University Hwasun Hospital
  • Samsung Medical Center
  • Korea University Guro Hospital
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Institut Català d'Oncologia
  • Hospital Madrid Norte Sanchinarro
  • Hospital Universitario Gregorio Marañon
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario Miguel Servet
  • Changhua Christian Hospital
  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • Chi Mei Medical Center
  • Chi Mei Hospital, Liouying
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Guys & St. Thomas Hospital
  • St. George's Hospital
  • The Royal Marsden NHS Foundation Trust
  • Imperial NHS Trust
  • Sarah Cannon Research Institute-London
  • The Christie NHS Foundation Trust
  • Mount Vernon Cancer Centre
  • The Royal Marsden NHS Foundation Trust - Haemato-Oncology
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tislelizumab

Investigator chosen chemotherapy

Arm Description

Tislelzumab on Day 1, given every 21 days

Paclitaxel will be administered on Day 1, given every 21 days or on a weekly schedule. OR docetaxel will be administered on Day 1, given 21 days. OR irinotecan will be administered on Days 1, 8, given 21 days.

Outcomes

Primary Outcome Measures

Overall survival (OS) in the Intention-to-Treat (ITT) Analysis Set
Length of time from study treatment initiation to death of any cause

Secondary Outcome Measures

Overall survival (OS) in the PDL-1 Positive Analysis Set
Length of time from study treatment initiation to death of any cause
Overall response rate (ORR)
Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria
Progression-free survival (PFS)
The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death
Duration of response (DOR)
The interval from the date of the first response (complete response or partial response) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause
Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30)
HRQoL as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus Cancer Module (EORTC QLQ-OES18)
HRQoL as Assessed by European Quality of Life 5-Dimensions Version (EQ-5D-5L Version)
Number of participants experiencing adverse events (AEs)
Number of participants experiencing immune-related AEs
Number of participants experiencing serious adverse events (SAEs)

Full Information

First Posted
January 29, 2018
Last Updated
January 16, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03430843
Brief Title
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 26, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma (ESCC)
Keywords
Unresectable, metastatic, second-line, squamous, esophagus, chemotherapy, paclitaxel, docetaxel, irinotecan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
513 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab
Arm Type
Experimental
Arm Description
Tislelzumab on Day 1, given every 21 days
Arm Title
Investigator chosen chemotherapy
Arm Type
Active Comparator
Arm Description
Paclitaxel will be administered on Day 1, given every 21 days or on a weekly schedule. OR docetaxel will be administered on Day 1, given 21 days. OR irinotecan will be administered on Days 1, 8, given 21 days.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
135-175 mg /m² administered IV given every 21 days, or 80-100mg/m2 administered IV weekly
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m2 administered IV
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
125mg/m2 administered IV
Primary Outcome Measure Information:
Title
Overall survival (OS) in the Intention-to-Treat (ITT) Analysis Set
Description
Length of time from study treatment initiation to death of any cause
Time Frame
approximately 2 years from date of first randomization
Secondary Outcome Measure Information:
Title
Overall survival (OS) in the PDL-1 Positive Analysis Set
Description
Length of time from study treatment initiation to death of any cause
Time Frame
Up to 2 years from date of first randomization
Title
Overall response rate (ORR)
Description
Clinical response rate of treatment (CR + PR) according to RECIST v1.1 criteria
Time Frame
2 years
Title
Progression-free survival (PFS)
Description
The interval from study treatment initiation until the determination of disease progression according to RECIST v1.1 criteria or death
Time Frame
2 years
Title
Duration of response (DOR)
Description
The interval from the date of the first response (complete response or partial response) is achieved to the earlier of the first documentation of definitive disease progression or death from any cause
Time Frame
2 years
Title
Health-Related Quality of Life (HRQoL) as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30)
Time Frame
2 years
Title
HRQoL as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus Cancer Module (EORTC QLQ-OES18)
Time Frame
2 years
Title
HRQoL as Assessed by European Quality of Life 5-Dimensions Version (EQ-5D-5L Version)
Time Frame
2 years
Title
Number of participants experiencing adverse events (AEs)
Time Frame
From the first dose date to 30 days after the last dose date
Title
Number of participants experiencing immune-related AEs
Time Frame
From the first dose date to 90 days after the last dose date
Title
Number of participants experiencing serious adverse events (SAEs)
Time Frame
From the first dose date to 30 days after the last dose date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC) Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC At least one measurable/evaluable lesion by RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization Adequate End organ function Key Exclusion Criteria: Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization Apparent 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 Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage Received prior therapies targeting PD-1 or PD-L1 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) Active brain or leptomeningeal metastasis. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse 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 Known history of Human Immunodeficiency Virus (HIV) Has cardiovascular risk factors Pregnant or breastfeeding woman. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Paton, Pharm.D.
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of Southern California Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-0112
Country
United States
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Millennium Oncology
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Imelda Ziekenhuis
City
Antwerp
ZIP/Postal Code
2600
Country
Belgium
Facility Name
UZ Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Cliniques universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Anhui Medical University - The Second Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
The First Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
71000
Country
China
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
400037
Country
China
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441000
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
The First People's Hospital Of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Huai'an Second People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223002
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
21008
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Facility Name
The First Hospital of Jinlin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Shandong Linyi Tumor Hospital
City
Linyi
State/Province
Shandong
ZIP/Postal Code
371300
Country
China
Facility Name
WeiFang People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Facility Name
Fudan Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
140100
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710014
Country
China
Facility Name
Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610071
Country
China
Facility Name
Yunnan Cancer Hospital - Oncology
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
CHRU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
CHRU de Brest Hôpital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Center Oscar Lambret - Alliance Member
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Prive Jean Mermoz
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
ICM Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Comprehensive Cancer Center-Gustave Roussy
City
Paris
ZIP/Postal Code
94805
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre de Lutte Contre le Cancer
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique Sainte-Anne
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Hamatologisch-Onkologische Praxis Eppendorf (HOPE)
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Universitatsklinikum Koln, Innere Medizin I
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitaetsmedizin Mannheim, II. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Kliniken Nordoberpfalz, Klinikum Weiden
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
PO Garibaldi-Nesima, ARNAS Garibaldi
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
AUSL della Romagna, Osp. degli Infermi
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Irccs Irst
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
AOU - Seconda Università degli Studi di Napoli
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU San Luigi di Orbassano
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Ospedale Guglielmo da Saliceto, AUSL Piacenza
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Facility Name
A.O.U. Pisana, Stabilimento di Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
AO Citta della Salute e della Scienza di Torino - Presidio O
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
100-0045
Country
Japan
Facility Name
Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Hyogo Cancer Center
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kindai University Nara Hospital
City
Ikoma
State/Province
Nara
ZIP/Postal Code
630-0293
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Saitama Cancer Center
City
Ina
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Nagaizumi
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kagawa University Hospital
City
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781-8555
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center - Oncology
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Seoul
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
8308
Country
Korea, Republic of
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Madrid
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Institut Català d'Oncologia
City
Madrid
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Changhua Christian Hospital
City
Changhua
State/Province
NAP
ZIP/Postal Code
500-06
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Chi Mei Hospital, Liouying
City
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Guys & St. Thomas Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute-London
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust - Haemato-Oncology
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35785595
Citation
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.
Results Reference
derived
PubMed Identifier
35442766
Citation
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.
Results Reference
derived

Learn more about this trial

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

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