CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 684 enrolled
Drug / intervention
Tislelizumab +1 moredrug
Likely dose
Tislelizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03412773
NCT03412773Phase 3Completed
CompareCT.gov

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

BeiGene·interventional·Posted Jan 26, 2018·Updated Oct 14, 2025

In Brief

A Phase 3 clinical trial evaluating Tislelizumab and Sorafenib for Hepatocellular Carcinoma (HCC). Completed, enrolled 684 participants across 122 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma (HCC)
CountriesChina, Czechia, France, Germany, Italy, Japan, Poland, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 26, 2018
Enrollment StartDec 18, 2017
Primary CompletionJul 11, 2022
Study CompletionDec 14, 2023
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 8.4 years ago

Interventions

Tislelizumabdrug

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

Sorafenibdrug

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