A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)
Purpose
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.
Condition
- Hepatocellular Carcinoma (HCC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Safety Run-In Sub-study |
Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability. |
|
|
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. |
|
|
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. |
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More Details
- Status
- Completed
- Sponsor
- BeiGene