Hepatocellular Carcinoma · Radiation · Definitive / Curative · Locally advanced HCC unsuitable for standard locoregional therapy

NRG/RTOG 1112

Clinical question: In locally advanced hcc unsuitable for standard locoregional therapy, what is the efficacy and safety of the evaluated intervention?

Registry: NCT01730937 · One underlying study; aliases and follow-up publications consolidated.

Multicentre phase III randomized trial; 193 randomized, 177 eligible; stopped early after standard-of-care change. Evidence cut-off: 13 November 2026.

Design, population and eligibility

Design / sample size

Multicentre phase III randomized trial; 193 randomized, 177 eligible; stopped early after standard-of-care change.

Eligibility

Locally advanced HCC unsuitable for/refractory to standard locoregional therapy; macrovascular invasion common; preserved liver function required.

Intervention

Personalized SBRT followed by sorafenib versus sorafenib alone.

SBRT 27.5–50 Gy in 5 fractions, followed by sorafenib.

Comparator

sorafenib alone.

Primary endpoint: OS primary; PFS, toxicity and quality of life secondary.

Key efficacy outcomes

Median OS 15.8 vs 12.3 months; unadjusted HR 0.77 (90% CI 0.59–1.01), one-sided p=0.06 (did not meet primary threshold). Stratification-adjusted HR 0.72 (95% CI 0.52–0.99), p=0.04. PFS 9.2 vs 5.5 months, HR 0.55 (0.40–0.75), p<0.001.

Reported outcome

15.8

Comparator: 12.3. 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 treatment-related AEs 47% vs 42%; treatment-related deaths 1 vs 2. Quality-of-life improvement at 6 months 35% vs 10% among assessed participants.

Clinical interpretation and limitations

The primary unadjusted OS endpoint was not statistically significant; adjusted analysis and PFS support a clinically meaningful signal. Early closure and limited sample size constrain certainty. Do not state that primary OS endpoint was unequivocally positive.

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.