Hepatocellular Carcinoma · Medical · Advanced / Metastatic · First-line unresectable HCC

CheckMate 9DW

Clinical question: In first-line unresectable hcc, what is the efficacy and safety of the evaluated intervention?

Registry: NCT04039607 · One underlying study; aliases and follow-up publications consolidated.

Open-label phase III RCT; 668 patients randomized 1:1. Evidence cut-off: 13 November 2026.

Design, population and eligibility

Design / sample size

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

Eligibility

Previously untreated unresectable HCC; trial population largely Child-Pugh A, ECOG 0–1.

Intervention

Nivolumab + ipilimumab versus investigator's choice lenvatinib or sorafenib.

Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for 4 doses, then nivolumab maintenance; comparator lenvatinib weight-based or sorafenib 400 mg twice daily.

Comparator

investigator's choice lenvatinib or sorafenib.

Primary endpoint: OS primary; response and safety secondary.

Key efficacy outcomes

Median OS 23.7 vs 20.6 months, HR 0.79 (95% CI 0.65–0.96), p=0.018. 24-month OS 49% vs 39%; 36-month OS 38% vs 24%; ORR 36.1% vs 13.2%.

Reported outcome

23.7

Comparator: 20.6. The bars are a simple display of the first reported pair only; consult the endpoint and time horizon above.

Safety and treatment delivery

Grade 3–4 TRAEs 41% vs 42%; treatment-attributed deaths 12 vs 3. Early crossing of OS curves: deaths increased during first 6 months with nivo/ipi, then curves separated.

Clinical interpretation and limitations

Positive first-line OS trial, but the early mortality hazard and higher treatment-related deaths are clinically important. Patient selection, liver reserve, immune contraindications and ability to tolerate early progression are essential.

Interpret the reported hazard ratios in the context of the prespecified endpoint, statistical hierarchy, follow-up maturity, crossover/subsequent therapy and enrolled population. Median survival differences are not risk differences and must not be converted into NNT.

Absolute effect

No NNT/NNH is displayed unless an absolute event-risk difference at a clearly stated fixed timepoint can be calculated from reported trial data. Median survival differences and hazard ratios alone do not support an NNT. The visual above uses reported outcome data only.

Primary publication and follow-up

Primary publication

Registry / follow-up / authoritative source

Source-level verification status: primary publication identified and key quoted outcomes transcribed; where full-text toxicity or procedural details were not available, the page explicitly flags the limitation rather than inferring values.

Current-practice context · 13 November 2026

This page separates historical trial results from contemporary practice. Verify the applicable jurisdictional guideline, regulatory approval, biomarker assay, liver function, comorbidity and treatment availability before applying the evidence. NCCN Guidelines Insights are not a substitute for the full NCCN guideline.

Guideline/regulatory reconciliation and browser-rendered QA remain scheduled for the subsequent quality-control pass.