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

Inclusion Criteria

• •1. Signed informed consent form.
• •2. Age ≥ 19 years at the time of signing the informed consent form.
• •3. Diagnosis of hepatocellular carcinoma (HCC) confirmed histologically or clinically according to the Korean Liver Cancer Association-National Cancer Center (KLCA-NCC) guidelines.
• •4. Patients with unresectable HCC who have experienced disease progression or treatment discontinuation due to toxicity during prior treatment with lenvatinib.
• •5. Presence of at least one measurable target lesion according to RECIST v1.1.
• •6. Child-Pugh classification A or B7 (score 7).
• •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• •8. Adequate hematologic and end-organ function defined by the following laboratory test results obtained within 14 days prior to testing (or enrollment):
• •* Hemoglobin ≥ 8.5 g/dL
• •* Absolute neutrophil count (ANC) ≥ 1,200/mm³
• •* Platelet count ≥ 60,000/μL
• •* Total bilirubin \< 3.5 mg/dL
• •* Serum albumin ≥ 2.5 g/dL
• •* AST and ALT ≤ 7 × upper limit of normal (ULN)
• •* Prothrombin time (INR ≤ 1.8 × ULN)
• •* Serum creatinine ≤ 2.0 × ULN or calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault equation)
• •9. Virological status of hepatitis confirmed and recorded through HBV and HCV screening.
• •* Participants with HBV or HCV infection must be receiving antiviral therapy according to institutional guidelines.
• •10. Women of childbearing potential must agree to maintain abstinence or use effective contraception (with an annual failure rate of \< 1%) from the time of signing the informed consent until at least 6 months after the last dose of the study drug. Male participants must agree to maintain abstinence or use effective contraception (with an annual failure rate of \< 1%) and refrain from sperm donation from the time of signing the informed consent until at least 6 months after the last dose of the study drug.