Hepatocellular Carcinoma · Medical · Advanced / Metastatic

CARES-310

Clinical question: What are the efficacy and safety outcomes in first-line unresectable/metastatic hcc?

Registry: NCT03764293 · International open-label phase III RCT; n=543 across 95 sites in 13 countries/regions. Evidence cut-off: 13 November 2026.

Design, population and treatment

Eligibility

Previously untreated unresectable/metastatic HCC; ECOG 0–1.

Intervention / comparator

Camrelizumab 200 mg IV q2w + rivoceranib 250 mg orally daily versus sorafenib 400 mg twice daily.

Design

International open-label phase III RCT; n=543 across 95 sites in 13 countries/regions.

Primary endpoint

Co-primary PFS (BICR) and OS.

Key efficacy outcomes

Final OS 23.8 vs 15.2 months, HR 0.64 (95% CI 0.52–0.79), one-sided p<0.0001. PFS 5.6 vs 3.7 months, HR 0.54 (0.44–0.67).

Safety and tolerability

Grade 3–4 treatment-related hypertension 38% vs 15%; AST increase 17% vs 5%; treatment-related serious AEs 25% vs 7%; treatment-related deaths 1 per arm.

Interpretation and limitations

Strong positive final OS result. Hypertension, hepatic laboratory abnormalities and bleeding risk need active management; study population predominantly Asian.

Median survival differences and hazard ratios must not be converted into NNT. Absolute-effect pictograms are only used when a fixed-time absolute event difference is defensibly reported.

Primary and supporting sources

Primary publication

Registry / follow-up source

Current-practice context · 13 November 2026

Historical trial findings are separated from current recommendations. Check current jurisdiction-specific guidelines, regulatory approval, liver function, biomarkers and patient factors before applying the evidence. Full guideline reconciliation and browser-rendered QA remain pending.