RATIONALE-301

NCT03412773 📎

Regimen

Experimental
tislelizumab
Control
sorafenib

Population

Systemic therapy-naive, histologically confirmed hepatocellular carcinoma, BCLC B/C, Child-Pugh A

Key finding

mOS 15.9 vs 14.1 mo (HR 0.85, 95.003% CI 0.71-1.02); **noninferiority met, superiority NOT met**; ORR 14.3% vs 5.4%; DoR 36.1 vs 11.0 mo — durable responses striking; mPFS 2.1 vs 3.4 mo (HR 1.11 — tisle numerically worse PFS); etiology HBV ~60% (global multiregional)

Source: PMID 37796513

Timeline

    Guideline citations

    • NCCN HCC (p.68)