Trials / Completed
CompletedNCT03412773
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 684 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W) |
| DRUG | Sorafenib | Sorafenib 400 mg orally (PO) twice daily (BID) |
Timeline
- Start date
- 2017-12-18
- Primary completion
- 2022-07-11
- Completion
- 2023-12-14
- First posted
- 2018-01-26
- Last updated
- 2025-10-14
- Results posted
- 2025-10-14
Locations
122 sites across 11 countries: United States, China, Czechia, France, Germany, Italy, Japan, Poland, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03412773. Inclusion in this directory is not an endorsement.