Adjuvant Everolimus in High-Risk Hepatocellular Carcinoma After Curative Resection (SEVERANCE Trial)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2030

Study Completion Date

July 30, 2030

Conditions
CarcinomHepatocellular
Interventions
DRUG

Certirobell®

Patients enrolled in the study will initiate oral administration of Certirobell® between 4 to 6 weeks after hepatic resection. The medication will be taken for a duration of 92 weeks, twice daily at approximately 12-hour intervals. The initial dosage is 1.0 mg per dose (twice daily). For patients with a Child-Pugh score of 6, the starting dose will be reduced to 0.75 mg per dose (twice daily). At each visit, the blood concentration of Certirovel will be measured, and the investigator will adjust the dosage as needed to maintain levels within the target range of 3-8 ng/mL. If HCC recurrence is confirmed during treatment, the administration of the drug will be discontinued.

All Listed Sponsors
lead

Yonsei University

OTHER