A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcino… (NCT03412773) | Clinical Trial Compass
CompletedPhase 3
A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)
United States684 participantsStarted 2017-12-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of HCC
✓. 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
✓. No prior systemic therapy for HCC (with the exception of HCC participants enrolled in the safety run-in substudy \[Japan only\])
✓. Measurable disease
✓. Child-Pugh score A
✓. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
✓. Adequate organ function
Exclusion criteria
✕. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
✕. Tumor thrombus involving main trunk of portal vein or inferior vena cava
✕. Loco-regional therapy to the liver within 28 days before randomization
✕. Clinical evidence of portal hypertension with bleeding esophageal or gastric varices at Screening, or within 6 months before randomization
✕. 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
What they're measuring
1
Safety Run-in Sub-study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: From the first dose to 30 days after the last dose, new anticancer therapy, or the analysis cutoff of December 14th, 2023 (a maximum of 64 months)
2
Safety Run-in Sub-study: Serum Concentration of Tislelizumab
Timeframe: Cycle 1 and Cycle 5 at end of infusion, 24 hand 72 hours post-dose, and 8 days and 15 days post-dose (each cycle was 3 weeks).
3
Main Study: Overall Survival (OS)
Timeframe: Through the primary analysis data cut-off date of July 11th, 2022 (up to approximately 55 months)
. Presence at Screening of active immune deficiency or autoimmune disease and/or prior history of any immune deficiency or autoimmune disease that may relapse
✕. 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
✕. History of interstitial lung disease or non-infectious pneumonitis, unless induced by radiation therapy