NCT07514429

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ju Hyun Shim · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

Lenvatinib is currently recognized as a standard first-line treatment for advanced hepatocellular carcinoma (HCC), having demonstrated non-inferiority to sorafenib in a phase 3 randomized clinical trial. It is also utilized as a second-line option following the failure of immunotherapy-based regimens. However, unlike sorafenib, there is a lack of prospective data regarding subsequent therapies following lenvatinib failure, which poses significant challenges in clinical decision-making. Regorafenib has demonstrated clinical efficacy and significant survival benefits compared to placebo in the RESORCE trial as a second-line treatment after sorafenib for Child-Pugh class A patients. Nevertheless, evidence supporting its use specifically in patients who have failed lenvatinib remains insufficient. This multicenter, single-arm, phase 2 study is designed to evaluate the efficacy and safety of regorafenib as a subsequent therapy for patients with unresectable HCC who have experienced disease progression or unacceptable toxicity during prior treatment with lenvatinib. Enrolled participants will receive regorafenib orally. The starting dose for Cycle 1 will be determined by the baseline Child-Pugh classification (160 mg once daily for Child-Pugh A; 120 mg once daily for Child-Pugh B). From Cycle 2 onwards, patients will maintain a standard regimen of 3 weeks on and 1 week off at the maximum tolerated dose. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The study will assess key efficacy endpoints including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR), alongside comprehensive safety evaluations.

Conditions

• Carcinoma, Hepatocellular
• Lenvatinib
• Treatment Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-05-31
• Completion: 2028-06-30
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: South Korea