Hepatocellular Carcinoma · Medical · Advanced / Metastatic

HEPATORCH

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

Registry: NCT04723004 · Randomized open-label phase III trial; n=326. Evidence cut-off: 13 November 2026.

Design, population and treatment

Eligibility

Previously untreated unresectable/metastatic HCC; age 18–75, ECOG 0–1.

Intervention / comparator

Toripalimab 240 mg IV q3w + bevacizumab 15 mg/kg q3w versus sorafenib 400 mg twice daily.

Design

Randomized open-label phase III trial; n=326.

Primary endpoint

Co-primary PFS (IRC) and OS.

Key efficacy outcomes

PFS 5.8 vs 4.0 months, HR 0.69 (95% CI 0.53–0.91), p=0.0086. Final OS 20.0 vs 14.5 months, HR 0.76 (0.58–0.99), p=0.039.

Safety and tolerability

Grade ≥3 AEs 63% vs 61%; discontinuation for AEs 13% vs 12%; treatment-related fatal AEs 1% each. Grade 3–4 hypertension 16% vs 12%; upper GI haemorrhage 6% vs 1%.

Interpretation and limitations

Positive phase III OS/PFS; China-centred population. Bleeding risk and portal-hypertension/variceal assessment are important with bevacizumab.

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.