Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorJu Hyun Shim
About this trial
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
Eligibility criteria
Qualifiers
Signed informed consent form.
Age ≥ 19 years at the time of signing the informed consent form.
Diagnosis of hepatocellular carcinoma (HCC) confirmed histologically or clinically according to the Korean Liver Cancer Association-National Cancer Center (KLCA-NCC) guidelines.
Patients with unresectable HCC who have experienced disease progression or treatment discontinuation due to toxicity during prior treatment with lenvatinib.
Disqualifiers
Albumin-bilirubin (ALBI) grade 3.
Fibrolamellar carcinoma or sarcomatoid carcinoma.
Prior treatment with regorafenib.
History of allogeneic stem cell transplantation or solid organ transplantation.
Trial design
Treatments tested in this trial
- Regorafenib (BAY 73-4506)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Ju Hyun Shim
Lead sponsor
Asan Medical Center
Sponsor institution
Boryung Pharmaceutical Co., Ltd
Collaborator
Samsung Medical Center
Collaborator
Seoul National University Hospital
Collaborator
Seoul National University Bundang Hospital
Collaborator
National Cancer Center, Korea
Collaborator
Hanyang University Guri Hospital
Collaborator
Source ClinicalTrials.gov