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A Study of Tislelizumab Versu...

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

Last Updated: 2025-10-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

684 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2023-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Safety Run-In Sub-study

Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability.

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)

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.

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)

Arm B: Sorafenib

Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit.

Group Type ACTIVE_COMPARATOR

Sorafenib

Intervention Type DRUG

Sorafenib 400 mg orally (PO) twice daily (BID)

Interventions

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Tislelizumab

Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)

Intervention Type DRUG

Sorafenib

Sorafenib 400 mg orally (PO) twice daily (BID)

Intervention Type DRUG

Other Intervention Names

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BGB-A317 Nexavar BAY43-9006

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director, MD

Role: STUDY_DIRECTOR

BeiGene

Locations

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Providence Medical Foundation

Fullerton, California, United States

Site Status

UCLA Hematologyoncology

Los Angeles, California, United States

Site Status

Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Umdnj Njms

Newark, New Jersey, United States

Site Status

Rj Zuckerberg Cancer Center

Lake Success, New York, United States

Site Status

Xcancerdayton Physician Network

Dayton, Ohio, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Ut Health San Antonio Mays Cancer Center

San Antonio, Texas, United States

Site Status

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status