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A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03412773•BeiGene

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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

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

Locations (122)

Providence Medical Foundation

Fullerton, California, United States

UCLA Hematologyoncology

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center

Orange, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Umdnj Njms

Newark, New Jersey, United States

Rj Zuckerberg Cancer Center

Lake Success, New York, United States

Xcancerdayton Physician Network

Dayton, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Ut Health San Antonio Mays Cancer Center

San Antonio, Texas, United States

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Key Dates

Start Date

December 18, 2017

Primary Completion Date

July 11, 2022

Completion Date

December 14, 2023

Last Updated

October 14, 2025

Enrollment

684

ACTUAL participants

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

Tislelizumab

DRUG

Sorafenib

DRUG

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NCT07291076

Hepatocellular Carcinoma (HCC)

View study

RECRUITING

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

NCT07365930

Hepatocellular Carcinoma (HCC)

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RECRUITINGPHASE4

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

Multiparametric MRI for Characterization of Hepatocellular Carcinoma