Hepatocellular Carcinoma and Liver Metastases · Radiation · Palliative

CCTG HE1

Clinical question: What are the efficacy and safety outcomes of painful hepatic cancer refractory to standard therapy; mixed hcc/liver metastases?

Registry: NCT02511522 · Open-label phase III RCT; n=66 (33 per arm); 23 HCC and 43 liver metastases. Evidence cut-off: 13 November 2026.

Design, eligibility and treatment

Population

HCC or liver metastases, refractory to standard therapy, ECOG 0–3, pain ≥4/10.

Intervention / comparator

8 Gy single-fraction liver RT + best supportive care versus best supportive care.

Design

Open-label phase III RCT; n=66 (33 per arm); 23 HCC and 43 liver metastases.

Primary endpoint

≥2-point BPI worst-pain improvement at 1 month.

Key efficacy outcomes

Among participants with both assessments, improvement 16/24 (67%) vs 4/18 (22%), p=0.0042; only 42/66 had both assessments.

Safety

Grade 3–4 abdominal pain 9% vs 3%; ascites 6% vs 3%; no serious AEs or treatment-related deaths.

Interpretation and limitations

Randomized phase III palliative evidence but mixed tumour population and missing patient-reported outcomes; not HCC-specific efficacy evidence.

Median survival differences and hazard ratios must not be converted into NNT. A patient pictogram is omitted unless a defensible fixed-time absolute event difference is reported.

Primary and supporting sources

Primary publication

Registry / supporting source

Primary-source data reviewed; the page explicitly identifies unavailable full-text toxicity details rather than imputing them.

Current-practice context · 13 November 2026

Historical trial results are distinct from current treatment recommendations. Check current jurisdiction-specific guidance, liver function, biomarker requirements, local expertise and regulatory availability before applying these findings. Comprehensive guideline reconciliation and browser-rendered QA remain pending.