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Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Sorafenib
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma (HCC) focused on measuring Advanced liver cancer, RATIONALE-301

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of HCC
  2. Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach
  3. No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only])
  4. Measurable disease
  5. Child-Pugh score A
  6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  7. Adequate organ function

Key Exclusion Criteria:

  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
  2. Tumor thrombus involving main trunk of portal vein or inferior vena cava
  3. Loco-regional therapy to the liver within 28 days before randomization
  4. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
  5. Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment
  6. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
  7. Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization
  8. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy
  9. QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening

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

Sites / Locations

  • Southern California Research Center
  • St. Jude Heritage Healthcare
  • University of California - Hematology and Oncology
  • Chao Family Comprehensive Cancer Center
  • Inland Empire Liver Foundation
  • Ingalls Memorial Hospital
  • Healthcare Research Network III, LLC
  • Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit
  • University Medical Center New Orleans
  • Massachusetts General Hospital Cancer Center
  • UMass Memorial Medical Center
  • Umdnj-Njms
  • Northwell Health/Monter Cancer Center
  • White Plains Hospital Center for Cancer Care - Oncology
  • Precision Cancer Research / Dayton Physicians Network
  • Hahnemann University Hospital - Gastroenterology Hepatology
  • Cancer Treatment Centers of America - Oncology
  • Vanderbilt University Medical Center (VUMC)
  • The Mays Cancer Center
  • The First Affiliated Hospital of Bengbu Medical College
  • Anhui Provincial Hospital
  • The First Affiliated Hospital Of Anhui Medical University
  • Anhui Medical University - The Second Hospital
  • Beijing Cancer Hospital
  • Chinese PLA General Hospital
  • 302 Military Hospital of China
  • Beijing YouAn Hospital, Capital Medical University
  • Cancer Hopital Chinese Academy of Medical Sciences
  • Fujian Medical University Union Hospital
  • Fujian Provincial Cancer Hospital
  • Guangdong General Hospital
  • Nanfang Hospital
  • Sun Yat-sen Memorial Hospital , Sun Yat-sen University
  • The First Affiliated Hospital, Sun Yat-sen University
  • The First Affiliated Hospital of Guangxi Medical University
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Hubei Cancer Hospital
  • Wuhan Union Hospital
  • Nanjing Bayi Hospital
  • Jiangsu Cancer Hospital
  • The First Affiliated Hospital of Soochow University
  • The Second Affiliated Hospital of Nanchang University
  • Jilin Cancer Hospital
  • The First Hospital of Jilin University
  • The Affiliated Hospital Of Qingdao University
  • Weifang People's Hospital
  • Shanghai Cancer Hospital of Fudan University
  • Zhongshan Hospital Fudan University
  • The First Affiliated Hospital Of XI'AN Jiaotong University
  • Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
  • Zhongnan Hospital of Wuhan University
  • The First Affiliated Hospital of Zhejiang University
  • Sir Run Run Shaw Hospital, Zhejiang University
  • Zhejiang Cancer Hospital
  • Peking Union Medical College Hospital
  • The First Affiliated Hospital of Chongqing Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice v Motole
  • CHU Amiens-Hopital Nord - Hépato-Gastroentérologie
  • CHU Cote De Nacre - Hepato-Gastro-Enterologie Et N
  • Hôpital Privé des Côtes d'Armor - Service oncologie
  • Hopital Robert DEBRE, CHU Reims
  • Hospitalier Jean Minjoz
  • CHU de Grenoble Alpes
  • Bichat-Beaujon Service Inter Hospitalier De Cancerologie
  • Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su
  • CHU Nantes -hopital hotel Dieu
  • CHU Saint Etienne
  • CHRU De Lille - Hôpital Claude Huriez
  • CHU de Nice - Hôpital de l'Archet II
  • CHU Saint Eloi - Pôle Digestif
  • Gustave Roussy - Medical Oncology
  • Hospital of Poitiers
  • Krankenhaus Nordwest gGmbH
  • Maria Gonzalez-Carmona
  • Stefan Pluntke
  • Universitätsklinikum Düsseldorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Köln
  • Universitätsklinikum Leipzig AöR
  • Universitätsmedizin Mainz
  • IRCCS Saverio De Bellis, AO Gastroenterologia
  • Medical Oncology
  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele di Catania
  • Ospedale S.Bortolo, AULSS n.6 Vicenza
  • Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Malattie
  • PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology
  • Ospedale Vito Fazzi, ASL Lecce
  • AOU Policlinico di Modena
  • IRCCS Policlinico San Matteo
  • Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncologia
  • Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
  • PO Umberto I, AO Ordine Mauriziano
  • Fujita Health University Hospital
  • Ehime Prefectural Central Hospital - Gastroenterology
  • Ogaki Municipal Hospital
  • Hokkaido University Hospital - Gastroenterology
  • Kanazawa University Hospital
  • Yokohama City University Medical Center
  • Kanagawa Cancer Center
  • University Hospital, Kyoto Prefectural Univ of Medicine
  • Nagasaki Medical Center
  • Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology
  • Osaka University Hospital
  • Chiba University Hospital
  • Sasaki Foundation Kyoundo Hospital
  • Nihon University Itabashi Hospital - Gastroenterological surgery
  • JRC Medical Center
  • National Center for Global Health and Medicine
  • Kyushu Medical Center
  • Kumamoto University Hospital
  • Iwate Medical University Hospital
  • Hyogo College of Medicine Hospital
  • Osaka International Cancer Institute
  • Tottori University Hospital
  • Wakayama Medical University
  • Osaka City General Hospital
  • Osaka National Hospital
  • Osaka City University Hospital
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Clinical Research Center Sp. z o.o., Medic-R Sp. K.
  • Uniwersyteckie Centrum Kliniczne
  • Wojewodzki Szpital Specjalistyczny im. Gromkowskiego we Wroclawiu
  • Institut Catalá d´Oncología (I.C.O.)
  • Hospital Universitario Vall d'Hebrón
  • Hospital Universitario Madrid Sanchinarro Centro integral Oncologico Clara Campal (CIOCC)
  • Hospital Universitari i Politecnic La Fe
  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology
  • Kaohsiung Medical University - Chung-Ho Memorial Hospital
  • Tri-Service General Hospital - Neihu Branch
  • China Medical University Hospital - Transplantology - Taichung
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Chi Mei Medical Center - YongKang
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
  • Queen Elizabeth Hospital - Clinical Reasearch
  • Royal Free Hospital London NHS Trust
  • King's College Hospital NHS Foundation Trust
  • The Christie NHS Foundation Trust - Oak Road Treatment Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Tislelizumab & Safety Run-In Substudy [Japan Only]

Arm B: Sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Safety Run-In Substudy[Japan only]: Percentage of participants with adverse events
Safety Run-In Substudy[Japan only]: Percentage of participants with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of tislelizumab in Japanese participants]
Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of Tislelizumab
Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of tislelizumab
Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of tislelizumab
Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against tislelizumab at Cmin
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

Secondary Outcome Measures

Objective Response Rate (ORR)
Progression-free survival (PFS)
Duration of Response (DOR)
Time to Progression (TTP)
Health-Related Quality of Life (HRQoL)
Disease Control Rate (DCR)
Clinical Benefit Rate (CBR)
Percentage of participants with adverse events
Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)
Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)
Safety Run-In Substudy[Japan only]: Duration of Response (DOR)
Safety Run-In Substudy[Japan only]: Overall Survival (OS)
Safety Run-In Substudy[Japan only]: Anti-tislelizumab antibody
Percentage of Participants With Clinically Significant Changes in Vital Signs Findings
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

Full Information

First Posted
January 3, 2018
Last Updated
June 30, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03412773
Brief Title
Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC
Official Title
RATIONALE-301: A Randomized, Open-label, Multicenter Phase 3 Study to Compare the Efficacy and Safety of BGB-A317 Versus Sorafenib as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
July 11, 2022 (Actual)
Study Completion Date
December 5, 2023 (Anticipated)

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

5. Study Description

Brief Summary
This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese participants. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese participants are recruited in this Phase 3 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma (HCC)
Keywords
Advanced liver cancer, RATIONALE-301

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm A: Tislelizumab & Safety Run-In Substudy [Japan Only]
Arm Type
Experimental
Arm Title
Arm B: Sorafenib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
200 mg once every 3 weeks (Q3W), intravenous dosing (IV)
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
Nexavar, BAY43-9006
Intervention Description
400 mg twice daily (BID), oral dosing
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
From date of randomization up to 4 years, approximately
Title
Safety Run-In Substudy[Japan only]: Percentage of participants with adverse events
Time Frame
From date of enrollment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Percentage of participants with dose-limiting toxicities (DLT) [Determination of the pivotal Phase 3 dose of tislelizumab in Japanese participants]
Time Frame
From the date of enrollment up to 28 days [DLT period].
Title
Safety Run-In Substudy[Japan only]: Maximum Concentration (Cmax) of Tislelizumab
Time Frame
From first dose of study treatment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Trough Serum Concentration (Cmin) of tislelizumab
Time Frame
From first dose of study treatment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Area Under the Curve (AUC) of tislelizumab
Time Frame
From first dose of study treatment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]:Anti-Drug Antibodies (ADA) against tislelizumab at Cmin
Time Frame
From first dose of study treatment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Vital Signs Findings
Time Frame
From date of enrollment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Time Frame
From date of enrollment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings
Time Frame
From date of enrollment up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
Time Frame
From date of enrollment up to 4 years, approximately.
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Time Frame
From date of randomization up to 4 years, approximately
Title
Progression-free survival (PFS)
Time Frame
From date of randomization up to 4 years, approximately
Title
Duration of Response (DOR)
Time Frame
From first determination of an objective response up to 4 years, approximately
Title
Time to Progression (TTP)
Time Frame
From date of randomization up to 4 years, approximately.
Title
Health-Related Quality of Life (HRQoL)
Time Frame
From date of enrollment up to 4 years, approximately.
Title
Disease Control Rate (DCR)
Time Frame
From first dose of study treatment up to 4 years, approximately
Title
Clinical Benefit Rate (CBR)
Time Frame
From first dose of study treatment up to 4 years, approximately
Title
Percentage of participants with adverse events
Time Frame
From date of screening up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Objective Response Rate (ORR)
Time Frame
From date of randomization up to 4 years, approximately.
Title
Safety Run-In Substudy[Japan only]: Progression-free survival (PFS)
Time Frame
From date of randomization up 4 years, approximately
Title
Safety Run-In Substudy[Japan only]: Duration of Response (DOR)
Time Frame
From date of randomization up 4 years, approximately
Title
Safety Run-In Substudy[Japan only]: Overall Survival (OS)
Time Frame
From date of randomization up 4 years, approximately
Title
Safety Run-In Substudy[Japan only]: Anti-tislelizumab antibody
Time Frame
From first dose of study treatment up 4 years, approximately
Title
Percentage of Participants With Clinically Significant Changes in Vital Signs Findings
Time Frame
From date of enrollment up to 4 years, approximately
Title
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
Time Frame
From date of enrollment up to 4 years, approximately
Title
Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings
Time Frame
From date of enrollment up to 4 years, approximately
Title
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings
Time Frame
From date of enrollment up to 4 years, approximately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed diagnosis of HCC Barcelona Clinic Liver Cancer (BCLC) Stage B or C disease not amenable to or progressing after loco-regional therapy and not amenable to a curative treatment approach No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy [Japan only]) Measurable disease Child-Pugh score A Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1 Adequate organ function Key Exclusion Criteria: Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology Tumor thrombus involving main trunk of portal vein or inferior vena cava Loco-regional therapy to the liver within 28 days before randomization Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization Bleeding or thrombotic disorder or any prescribed anticoagulant requiring therapeutic international normalized ratio monitoring (eg, warfarin or similar agents) at Screening, or within 6 months before randomization/enrollment Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before randomization History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy QT interval corrected for heart rate (QTc) (corrected by Fridericia's method) > 450 msec at Screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaxi Chen, MD
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
St. Jude Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California - Hematology and Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Healthcare Research Network III, LLC
City
Tinley Park
State/Province
Illinois
ZIP/Postal Code
60487
Country
United States
Facility Name
Ochsner Medical Center (OMC) - New Orleans ACCRU Network Sit
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2429
Country
United States
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Umdnj-Njms
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Northwell Health/Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
White Plains Hospital Center for Cancer Care - Oncology
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
Precision Cancer Research / Dayton Physicians Network
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Hahnemann University Hospital - Gastroenterology Hepatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Cancer Treatment Centers of America - Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Vanderbilt University Medical Center (VUMC)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Mays Cancer Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital Of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Anhui Medical University - The Second Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
302 Military Hospital of China
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing YouAn Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Cancer Hopital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Sun Yat-sen Memorial Hospital , Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
400037
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430023
Country
China
Facility Name
Nanjing Bayi Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Affiliated Hospital Of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
ZIP/Postal Code
261000
Country
China
Facility Name
Shanghai Cancer Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
The First Affiliated Hospital Of XI'AN Jiaotong University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
City
Sichuan
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Wuhan
ZIP/Postal Code
430071
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Fakultni nemocnice Brno
City
Brno
State/Province
Brno-Mesto
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
CHU Amiens-Hopital Nord - Hépato-Gastroentérologie
City
Somme
State/Province
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Cote De Nacre - Hepato-Gastro-Enterologie Et N
City
Caen, Cedex 05
State/Province
Basse-Normandie
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Privé des Côtes d'Armor - Service oncologie
City
Plérin
State/Province
Bretagne
ZIP/Postal Code
22190
Country
France
Facility Name
Hopital Robert DEBRE, CHU Reims
City
Reims
State/Province
Champagne-Ardenne
ZIP/Postal Code
51100
Country
France
Facility Name
Hospitalier Jean Minjoz
City
Besançon
State/Province
Franche-Comté
ZIP/Postal Code
25030
Country
France
Facility Name
CHU de Grenoble Alpes
City
La Tronche
State/Province
Isere
ZIP/Postal Code
38700
Country
France
Facility Name
Bichat-Beaujon Service Inter Hospitalier De Cancerologie
City
Clichy Cedex
State/Province
Lie-de-France
ZIP/Postal Code
92118
Country
France
Facility Name
Hopital Paul Brousse- Aphp Hopitaux Universitairees Paris Su
City
Villejuif
State/Province
Lie-de-France
ZIP/Postal Code
94800
Country
France
Facility Name
CHU Nantes -hopital hotel Dieu
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
4400
Country
France
Facility Name
CHU Saint Etienne
City
Rahon
State/Province
Lyon
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU De Lille - Hôpital Claude Huriez
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Nice - Hôpital de l'Archet II
City
Nice
State/Province
Provence-Alpes-Côte-d'Azur
ZIP/Postal Code
3200
Country
France
Facility Name
CHU Saint Eloi - Pôle Digestif
City
Bretagne
State/Province
Rennes Cedex
Country
France
Facility Name
Gustave Roussy - Medical Oncology
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Hospital of Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
Krankenhaus Nordwest gGmbH
City
Frankfurt/Main
State/Province
Hessen
Country
Germany
Facility Name
Maria Gonzalez-Carmona
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53105
Country
Germany
Facility Name
Stefan Pluntke
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
Country
Germany
Facility Name
IRCCS Saverio De Bellis, AO Gastroenterologia
City
Castellana Grotte
State/Province
Bari
ZIP/Postal Code
70013
Country
Italy
Facility Name
Medical Oncology
City
Feltre
State/Province
Belluno
Country
Italy
Facility Name
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele di Catania
City
Catania
State/Province
Catani
ZIP/Postal Code
95123
Country
Italy
Facility Name
Ospedale S.Bortolo, AULSS n.6 Vicenza
City
Vicenza
State/Province
Veneto
Country
Italy
Facility Name
Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Malattie
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
PO di Cremona, ASST di Cremona - Oncologia - Cremona - Radiology
City
Cremona
Country
Italy
Facility Name
Ospedale Vito Fazzi, ASL Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
AOU Policlinico di Modena
City
Modena
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncologia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS
City
Roma
ZIP/Postal Code
144
Country
Italy
Facility Name
PO Umberto I, AO Ordine Mauriziano
City
Torino
Country
Italy
Facility Name
Fujita Health University Hospital
City
Toyoake
State/Province
Aiti [Aichi]
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Ehime Prefectural Central Hospital - Gastroenterology
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
State/Province
Gihu [Gifu]
Country
Japan
Facility Name
Hokkaido University Hospital - Gastroenterology
City
Sapporo
State/Province
Hokkaidô [Hokkaido]
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa-shi
State/Province
Isikawa [Ishikawa]
ZIP/Postal Code
9208641
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural Univ of Medicine
City
Kyoto-shi
State/Province
Kyôto [Kyoto]
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Nagasaki Medical Center
City
Omura
State/Province
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Kinki University Hospital, Faculty of Medicine - Hematology & Clinical Oncology
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
State/Province
Tiba [Chiba]
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Sasaki Foundation Kyoundo Hospital
City
Chiyoda-Ku
State/Province
Tokyo
ZIP/Postal Code
101-0062
Country
Japan
Facility Name
Nihon University Itabashi Hospital - Gastroenterological surgery
City
Itabashi-ku
State/Province
Tôkyô [Tokyo]
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
JRC Medical Center
City
Shibuya-ku
State/Province
Tôkyô [Tokyo]
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
National Center for Global Health and Medicine
City
Shinjuku-ku
State/Province
Tôkyô [Tokyo]
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya-shi
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Tottori University Hospital
City
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Wakayama Medical University
City
Wakayama-shi
ZIP/Postal Code
641-8509
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
State/Province
Ôsaka [Osaka]
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka National Hospital
City
Osaka
State/Province
Ôsaka [Osaka]
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
State/Province
Ôsaka [Osaka]
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Clinical Research Center Sp. z o.o., Medic-R Sp. K.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Gromkowskiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
51-149
Country
Poland
Facility Name
Institut Catalá d´Oncología (I.C.O.)
City
Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario Madrid Sanchinarro Centro integral Oncologico Clara Campal (CIOCC)
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
Country
Spain
Facility Name
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Gastroenterology
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University - Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Tri-Service General Hospital - Neihu Branch
City
New Taipei
Country
Taiwan
Facility Name
China Medical University Hospital - Transplantology - Taichung
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
705
Country
Taiwan
Facility Name
Chi Mei Medical Center - YongKang
City
Tainan
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
Queen Elizabeth Hospital - Clinical Reasearch
City
Birmingham
ZIP/Postal Code
B152TH
Country
United Kingdom
Facility Name
Royal Free Hospital London NHS Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust - Oak Road Treatment Centre
City
Withington
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30969136
Citation
Qin S, Finn RS, Kudo M, Meyer T, Vogel A, Ducreux M, Macarulla TM, Tomasello G, Boisserie F, Hou J, Li X, Song J, Zhu AX. RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Future Oncol. 2019 Jun;15(16):1811-1822. doi: 10.2217/fon-2019-0097. Epub 2019 Apr 10.
Results Reference
result

Learn more about this trial

Phase 3 Study of Tislelizumab Versus Sorafenib in Participants With Unresectable HCC

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