Randomized phase II study comparing two doses of regorafenib in second-line treatment for advanced hepatocellular carcinoma.

ABSTRACT:

Background & aims

The RESORCE trial confirmed regorafenib as a second-line treatment for advanced hepatocellular carcinoma (HCC) in patients who tolerated sorafenib. However, its safety and efficacy in patients with diverse treatment histories remain unknown. The REGAIN study sought to assess regorafenib in patients not included in the RESORCE trial.

Methods

This single-center, randomized, open-label, dose-comparison trial included patients with HCC who had previously received sorafenib 200 mg/day or 400 mg every other day (Arm A), lenvatinib (Arm B), or atezolizumab plus bevacizumab (Arm C). Patients were randomly assigned to receive regorafenib at the standard (160 mg/day) or reduced (80 mg/day) starting dose. For early safety assessment, discontinuation as the result of a

SUBMITTER: Koroki K 

PROVIDER: S-EPMC12478257 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature