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NOT YET RECRUITING
NCT07514429
PHASE2

Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial

Sponsor: Ju Hyun Shim

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of regorafenib as a subsequent therapy for patients with hepatocellular carcinoma (HCC) who have failed prior lenvatinib treatment. This investigational study aims to assess the therapeutic benefits and safety profile of regorafenib in patients whose disease has progressed following the use of lenvatinib, a targeted therapy for hepatocellular carcinoma

Official title: Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: A Phase 2 RELEVANT-HCC Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-03-15

Completion Date

2028-06-30

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Regorafenib (BAY 73-4506)

"Participants with unresectable hepatocellular carcinoma who have failed prior lenvatinib treatment will receive oral regorafenib. The starting dose for Cycle 1 is 160 mg once daily for patients with Child-Pugh class A, and 120 mg once daily for patients with Child-Pugh class B. From Cycle 2 onwards, regorafenib will be administered at the maximum tolerated dose on a schedule of 3 weeks on and 1 week off (28-day cycle). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Locations (1)

Asan Medical Center

Seoul, South Korea