71MO - Randomized phase II study of adjuvant radiotherapy after curative resection of hepatocellular carcinoma with narrow margin (≤1 cm) (RAISE)

Background

Narrow margin (≤1 cm) is a risk factor for recurrence after hepatectomy for hepatocellular carcinoma (HCC) patients. This study aimed to investigate to efficacy and safety of postoperative adjuvant intensity modulated radiation therapy (IMRT) for HCC patients with narrow margin.

Methods

In this prospective, phase II, randomized, open-labeled, controlled clinical trial, HCC patients with narrow margin were randomly assigned (1:1) after hepatectomy to receive either IMRT of 50 Gy or observation stratified by tumor size and microvascular invasion. The primary endpoint was to demonstrate an recurrence-free survival (RFS) benefit for adjuvant IMRT in the intent to treat (ITT) population (80% power to detect RFS hazard ratio [HR] of 0.54 [Arm IMRT vs. observation] with α = 0.05 on stratified two-sided log-rank test; full information: 84 events in 148 patients). Secondary end points included time to recurrence (TTR), over survival (OS) and safety.

Results

Between January 15, 2019, and June 22, 2022, 118 patients were enrolled; 59 patients with HCC curative resected with narrow margin were randomly assigned to the IMRT group (RT group) and 59 to the follow up group (FU group). Clinicopathological characteristics were balanced between the two groups. The 6-, 12-, and 18-month RFS rates for RT group were 97.7%, 90.1%, and 83.5%, and were 88.3%, 75.9%, and 65.7% for FU group, respectively. The RFS were significantly better in the RT group than in the FU group (p=0.036, respectively). No patients in the RT group experienced grade 3 or more severe adverse events (AEs).

Conclusions

Adjuvant RT after hepatectomy may bring survival benefits of RFS for HCC patients with narrow margin.

Clinical trial identification

NCT03732105.

Editorial acknowledgement

Legal entity responsible for the study

The First Affiliated Hospital of Sun Yat-sen University.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.