A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)

September 24, 2025 updated by: BeiGene

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

This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
684

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical College
      • Hefei, Anhui, China, 230000
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230601
        • The second hospital of Anhui medical university
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100039
        • Military Hospital of China
      • Beijing, Beijing Municipality, China, 100069
        • Beijing Youan Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 630014
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, Sun Yat Sen University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin medical university cancer hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University Wuhan
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • General Hospital of Eastern Theater Command
      • Nanjing, Jiangsu, China, 210008
        • Jiangsu Province Cancer Hospital
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130021
        • Jilin Province Peoples Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University Branch Laoshan
      • Weifang, Shandong, China, 261000
        • Weifang Peoples Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Fudan University Shanghai Cancer Center
      • Shanghai, Shanghai Municipality, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310003
        • The first Affiliated Hospital, Zhejiang University School of Medicine
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
      • Prague, Czechia, 150 06
        • Fakultni nemocnice v Motole
  • France
      • Caen, France, 14033
        • CHU Caen Normandie
      • Clichy, France, 92210
        • Hopital Beaujon
      • Doubs, France, 25030
        • CHU Besançon Hopital Jean Minjoz
      • Grenoble, France, 38043
        • Chu de Grenoble Oncology
      • Lille, France, 59037
        • Chru de Lille Hopital Claude Huriez Hepato Gastro Enterologie
      • Montpellier, France, 34295
        • Chu Montpellier Hopital Saint Eloi
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire Nantes Hotel Dieu
      • Nice, France, 6200
        • Hopital Larchet Chu Nice
      • Poitiers, France, 86000
        • Chu de Poitiers Site de La Mileterie
      • Reims, France, 51056
        • Hôpital Robert Debré
      • Saint-Priest-en-Jarez, France, 42270
        • CHU Saint Etienne Hopital Nord
      • Villejuif, France, 94805
        • Institut Gustave Roussy
      • Villejuif, France, 94800
        • Hôpital Paul Brousse APHP
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Berlin
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Cologne, Germany, 50937
        • Uniklinik Koln (Aor)
      • Düsseldorf, Germany, 40225
        • Universitatsklinikum Dusseldorf
      • Essen, Germany, 45136
        • Kliniken Essen Mitte Evang Huyssens Stiftung
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig Aor
  • Italy
      • Bologna, Italy, 40138
        • Policlinico Sorsola Malpighi, Aou Di Bologna
      • Cremona, Italy, 26100
        • Po Di Cremona, Asst Di Cremona Oncologia Medica
      • Modena, Italy, 41124
        • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo, Università degli studi di Pavi
      • Peschiera del Garda, Italy, 37019
        • Ulssdolomiti
      • Torino, Italy, 10128
        • Po Umberto I, Ao Ordine Mauriziano
      • Vicenza, Italy, 36100
        • Osp Sbortolo, Ulss Berica
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital Gastroenterological Medicine
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural Univ of Medicine
      • Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital
      • Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Tottori, Japan, 683-8504
        • Tottori University Hospital Multidisciplinary Internal Medicine
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Ehime Prefectural Central Hospital Gastroenterologic Medicine
    • Fukuoka
      • Fukuokacity, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
    • Gifu
      • Ōgaki, Gifu, Japan, 503-8502
        • Ogaki Municipal Hospital Gastroenterological Medicine
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Nishinomiyashi, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Iwate
      • Yahabacho Shiwagun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center Gastroenterological Center
    • Nagasaki
      • Ōmura, Nagasaki, Japan, 856-8562
        • National Hospital Organization Nagasaki Medical Center Gastroenterology
    • Osaka
      • Osakashi, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osakashi, Osaka, Japan, 540-0006
        • NHO Osaka National Hospital
      • Sayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Suitashi, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Tokyo
      • Bunkyoku, Tokyo, Japan, 1138655
        • Sasaki Foundation Kyoundo Hospital Hepatology
      • Itabashiku, Tokyo, Japan, 173-8610
        • Nihon University Itabashi Hospital Gastroenterological Surgery
      • Shibuyaku, Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center Gastroenterology
      • Shinjukuku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Wakayama Medical University
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Poznan, Poland, 60-569
        • Clinical Research Center Sp Z Oo, Medic R Sp K
      • Warsaw, Poland, 02-034
        • Narodowy Instytut Onkologii Im Marii Skodowskiej Curie Pastwowy Instytut Badawczy
      • Wroclaw, Poland, 51-149
        • Centrum Badan Klinicznych
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall dHebron
      • Barcelona, Spain, 08908
        • Institut Catala Doncologia
      • Madrid, Spain, 28050
        • Hospital Universitario Hm Madrid Sanchinarro
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital Gastroenterology
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan City, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 114
        • Tri Service General Hospital
      • Taoyuan District, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Greater Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital London Nhs Trust
      • London, United Kingdom, SE5 9RS
        • Kings College
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation
      • Los Angeles, California, United States, 90095
        • UCLA Hematologyoncology
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New Jersey
      • Newark, New Jersey, United States, 07840
        • Umdnj Njms
    • New York
      • Lake Success, New York, United States, 11042
        • Rj Zuckerberg Cancer Center
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Xcancerdayton Physician Network
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio Mays Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Safety Run-In Sub-study Eligibility Criteria: The study included adult Japanese participants (≥ 20 years) with histologically confirmed hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) Stage C or B. Eligible participants had either received, were ineligible for, or declined standard treatment. Additional requirements were a Child-Pugh A classification within 7 days before enrollment, at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and an Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤ 1.

Main Study 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

Main Study 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Safety Run-In Sub-study
Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability.
Drug: Tislelizumab
Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)
Other Names:
  • BGB-A317
Experimental: Arm A: Tislelizumab
Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy.
Drug: Tislelizumab
Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)
Other Names:
  • BGB-A317
Active Comparator: Arm B: Sorafenib
Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit.
Drug: Sorafenib
Sorafenib 400 mg orally (PO) twice daily (BID)
Other Names:
  • Nexavar
  • BAY43-9006

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Run-in Sub-study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)

An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality.

A serious adverse event (SAE) is defined as any adverse event that:

  • Resulted in death
  • Was life-threatening
  • Required or prolonged hospitalization
  • Caused disability/incapacity
  • Lead to a congenital anomaly/birth defect
  • Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)
Safety Run-in Sub-study: Serum Concentration of Tislelizumab
Time Frame: Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks).
Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only.
Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks).
Main Study: Overall Survival (OS)
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) as Assessed by Blinded Independent Review Committee (BIRC)
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Defined as the percentage of participants who had partial response or complete response as determined by Blinded Independent Review Committee (BIRC) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in all randomized participants with measurable disease at baseline.

ORR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Overall Response Rate (ORR) as Assessed by the Investigator
Time Frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized participants with measurable disease at baseline.
Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Progression Free Survival (PFS) as Assessed by BIRC
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the BIRC per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS.

PFS was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Progression Free Survival (PFS) Assessed by the Investigator
Time Frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Kaplan-Meier methodology was used to estimate the median PFS.
Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Duration of Response (DOR) as Assessed by BIRC
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as determined by the BIRC per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology.

DOR was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Duration of Response (DOR) Assessed by the Investigator
Time Frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Defined as the time from the first occurrence of a documented objective response until the first documentation of progression or death from any cause, whichever occurred first, as assessed by the investigator per RECIST v1.1. Median DOR was estimated using Kaplan-Meier methodology.
Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Time to Progression (TTP) Assessed by BIRC
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the BIRC per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology.

TTP was not assessed by the BIRC for participants in the sub-study, and this was not a pre-specified sub-study endpoint.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Time to Progression (TTP) as Assessed by the Investigator
Time Frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by the investigator per RECIST v1.1. Median TTP was estimated using Kaplan-Meier methodology.

TTP was not a pre-specified sub-study endpoint.
Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Safety Run-in Sub-study: Overall Survival
Time Frame: Up a to 64 months
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Up a to 64 months
Disease Control Rate (DCR) as Assessed by BIRC
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the BIRC per RECIST v1.1.

DCR was not a pre-specified endpoint for participants in the sub-study.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Disease Control Rate (DCR) as Assessed by the Investigator
Time Frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease as assessed by the investigator per RECIST v1.1.

DCR was not a pre-specified endpoint for participants in the sub-study.
Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Clinical Benefit Rate (CBR) as Assessed by BIRC
Time Frame: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)

Defined as the percentage of participants whose best overall response (BOR) was complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the BIRC per RECIST v1.1.

CBR was not a pre-specified endpoint for participants in the sub-study.
Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
Clinical Benefit Rate (CBR) as Assessed by the Investigator
Time Frame: Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)

Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease greater than or equal to 24 weeks in duration, as assessed by the investigator per RECIST v1.1.

CBR was not a pre-specified endpoint for participants in the sub-study.
Through the study completion data cut-off date of December 14th, 2023 (up to approximately 65 months)
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Hepatocellular Carcinoma 18 Questions (EORTC QLQ HCC 18) Index Score at Cycle 4
Time Frame: Baseline to Cycle 4 (each cycle was 21 days)

The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life.

The EORTC QLQ-HCC18 was not assessed for participants in the sub-study.
Baseline to Cycle 4 (each cycle was 21 days)
Change From Baseline in the European EORTC QLQ HCC 18 Index Score at Cycle 6
Time Frame: Baseline to Cycle 6 (Each cycle was 21 days)

The EORTC QLQ-HCC18 is a questionnaire specifically designed to assess health-related quality of life in participants with hepatocellular carcinoma. It includes six symptom scales measuring Fatigue (3 items), Jaundice (2 items), Body Image (2 items), Nutrition (5 items), Pain (2 items), Fever (2 items) and two single items measuring Sex Life and Abdominal Swelling. Participants respond on a scale from 1 = "Not at all" to 4 = "Very Much. Raw scores are transformed into a 0 to 100 scale using linear transformation. The HCC18 Index score is calculated from each of the 6 symptom scales and the 2 single items, and ranges from 0 to 100. Higher scores indicate greater symptom burden or worse quality of life.

The HEORTC QLQ-HCC18 was not assessed in participants in the sub-study.
Baseline to Cycle 6 (Each cycle was 21 days)
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Score at Cycle 4
Time Frame: Baseline to Cycle 4 (each cycle was 21 days)

The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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.

The EORTC QLQ-C30 was not assessed in participants in the sub-study.
Baseline to Cycle 4 (each cycle was 21 days)
Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Score at Cycle 6
Time Frame: Baseline to Cycle 6 (each cycle was 21 days)

The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of participants with cancer. 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.

The EORTC QLQ-C30 was not assessed in participants in the sub-study.
Baseline to Cycle 6 (each cycle was 21 days)
Change From Baseline in the European Quality of Life 5 Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS) at Cycle 4
Time Frame: Baseline to Cycle 4 (each cycle was 21 days)

The EQ-5D-5L comprises a descriptive module and a Visual Analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status.

The EQ-5D-5L VAS was not assessed in participants in the sub-study.
Baseline to Cycle 4 (each cycle was 21 days)
Change From Baseline in the EQ-5D-5L VAS at Cycle 6
Time Frame: Baseline to Cycle 6 (each cycle was 21 days)

The EQ-5D-5L comprises a descriptive module and a visual analogue scale (VAS). The EQ-5D-5L VAS measures respondent's self-rated health status on a 0 to 100 scale, with 100 = 'the best health you can imagine' and 0 = 'the worst health you can imagine'. Higher scores on VAS indicate higher health status.

The EQ-5D-5L VAS was not assessed in participants in the sub-study.
Baseline to Cycle 6 (each cycle was 21 days)
Main Study: Number of Participants With Treatment-emergent Adverse Events
Time Frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the study completion analysis cutoff on December 14th, 2023 (a maximum of 61 months for participants in Arm A and 63 months for participants in Arm B).

An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality.

A serious adverse event (SAE) is defined as any adverse event that:

  • Resulted in death
  • Was life-threatening
  • Required or prolonged hospitalization
  • Caused disability/incapacity
  • Lead to a congenital anomaly/birth defect
  • Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
From the first dose to 30 days after the last dose, new anticancer therapy, or the study completion analysis cutoff on December 14th, 2023 (a maximum of 61 months for participants in Arm A and 63 months for participants in Arm B).
Safety Run-in Sub-study: Number of Participants Who Developed Anti-tislelizumab Antibodies
Time Frame: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)

Treatment-emergent anti-drug antibodies (ADA): participants who were ADA negative at baseline and ADA positive post-baseline.

Treatment-boosted ADA: participants who were ADA positive at baseline that was boosted to a 4-fold or higher-level following drug administration.

ADA assessments were not performed for participants enrolled in the main study.
From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, MD, BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-A317-301
  • 2017-002423-19 (EudraCT Number)
  • CTR20170882 (Registry Identifier: ChinaDrugTrials)
  • JapicCTI-194569 (Registry Identifier: Japic)
  • RATIONALE-301 (Other Identifier: BeiGene)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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