Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial (NCT07514429) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Regorafenib After Failure of Lenvatinib in Patients With Unresectable HCC: The RELEVANT-HCC Trial
South Korea24 participantsStarted 2026-03-15
Plain-language 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
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Presence of at least one measurable target lesion according to RECIST v1.1.
✓. Child-Pugh classification A or B7 (score 7).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
✓. Adequate hematologic and end-organ function defined by the following laboratory test results obtained within 14 days prior to testing (or enrollment):
Exclusion criteria
✕. Albumin-bilirubin (ALBI) grade 3.
✕. Fibrolamellar carcinoma or sarcomatoid carcinoma.
✕. Prior treatment with regorafenib.
✕. History of allogeneic stem cell transplantation or solid organ transplantation.
✕
What they're measuring
1
progression free survival
Timeframe: From date of first dose until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
. Active brain metastases or leptomeningeal metastases.
✕. History of malignancy other than hepatocellular carcinoma (HCC) within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year survival rate \> 90%).
✕. Severe cardiovascular disease within 3 months prior to the start of study therapy (e.g., New York Heart Association \[NYHA\] Class II or higher heart disease, myocardial infarction, or cerebrovascular accident); uncontrolled serious medical comorbidities, including unstable arrhythmia or unstable angina; or other significant medical conditions or abnormal findings that, in the opinion of the investigator, may increase the risk associated with study participation.
✕. Female participants who are pregnant or breastfeeding, or male or female participants of reproductive potential who are unwilling to use effective contraception from screening until 6 months after the last dose of the study drug.