Hepatocellular Carcinoma · Medical · Adjuvant / Postoperative

IMbrave050

Clinical question: What are the efficacy and safety outcomes in high-risk recurrence after curative-intent resection or ablation?

Registry: NCT04102098 · Open-label phase III RCT; n=668 randomized 1:1. Evidence cut-off: 13 November 2026.

Design, population and treatment

Eligibility

High-risk HCC after curative-intent resection or ablation; CTP A population.

Intervention / comparator

Atezolizumab 1,200 mg IV + bevacizumab 15 mg/kg IV q3w for 17 cycles versus active surveillance; crossover after recurrence permitted.

Design

Open-label phase III RCT; n=668 randomized 1:1.

Primary endpoint

RFS primary; OS secondary.

Key efficacy outcomes

Initial interim RFS HR 0.72 (adjusted 95% CI 0.53–0.98), p=0.012. Updated 2026 analysis: RFS HR 0.90 (95% CI 0.72–1.12); OS HR 1.26 (0.85–1.87), immature.

Safety and tolerability

Initial grade 3–4 AEs 41% vs 13%; grade 5 AEs 2% vs <1%; both agents discontinued for AEs in 9%. Updated safety consistent.

Interpretation and limitations

Initial RFS benefit was not sustained. 2026 update concludes benefit-risk does not support routine adjuvant atezolizumab/bevacizumab. Keep initial and updated reports together as one trial.

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.