None listed
Conditions
Interventions
Drug : Patients enrolled in the study will initiate oral administration of Certirovel® between 4 to 6 weeks after hepatic resection. The medication will be taken for a duration of 92 weeks, twice dail
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "• Individuals who voluntarily provide written informed consent to participate in this clinical trial • Adults aged =20 years and <75 years • Patients who have undergone curative resection for hepatocellular carcinoma (HCC) • Histologically confirmed HCC with negative surgical margins (R0 resection) • Patients classified as high risk for HCC recurrence • No evidence of extrahepatic metastasis • Patients who have fully recovered from surgery at the time of study drug initiation • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • Normal liver function or Child-Pugh Class A (Child-Pugh Score of 5 or 6) • Patients for whom alternative drug therapy is considered inappropriate and who are expected to benefit from administration of the investigational drug, as determined by the investigator • For women of childbearing potential: willingness to either abstain from sexual intercourse or use highly effective contraception† during the study drug administration period and for 8 weeks after discontinuation • For male participants: willingness to either abstain from sexual intercourse or use a condom during the study drug administration period and for 8 weeks after discontinuation †Highly effective contraception is defined as methods with a failure rate of less than 1% per year, including bilateral tubal occlusion, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Methods such as calendar-based methods, ovulation prediction, symptothermal methods, and post-ovulation methods are not considered adequate contraception."
Exclusion criteria
Exclusion criteria: • Patients diagnosed with combined hepatocellular-cholangiocarcinoma (HCC-CCC) • Presence of clinically significant ascites • History of hepatic encephalopathy • History of variceal bleeding within 6 months prior to hepatic resection • Autoimmune diseases or immunodeficiency disorders • Serious cardiovascular diseases, including acute myocardial infarction, acute coronary syndrome, stroke, or heart failure of New York Heart Association (NYHA) Class II or higher • History of malignancies other than HCC within the past 5 years • Patients with hereditary metabolic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption • Patients currently taking medication for psychiatric disorders • Absolute neutrophil count (ANC) 3 times the upper limit of normal (ULN) • Alkaline phosphatase level > 2.5 times the ULN • Proteinuria defined as a urine protein-to-creatinine ratio > 1.0 g/gCr or = 2+ on urine dipstick • Patients who received systemic therapy prior to hepatic resection • Prior treatment with anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapies • Renal impairment with estimated glomerular filtration rate (eGFR) 350 mg/dL or triglycerides > 500 mg/dL • History of severe acute (within the past 4 weeks) or chronic hypersensitivity reactions requiring treatment to everolimus or drugs with a similar chemical structure • Pregnant or breastfeeding women, women who are possibly pregnant, or women of childbearing potential who are unable to use highly effective contraception† during the study period and for 8 weeks after the last dose • Any condition deemed by the investigator to render the patient unsuitable for participation in the clinical trial †Highly effective contraception is defined as methods with a failure rate of less than 1% per year, including bilateral tubal occlusion, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Methods such as calendar-based methods, ovulation prediction, symptothermal methods, and post-ovulation methods are not considered adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate;2-year HCC recurrence rate;Overall survival;Time to recurrence;Safety | — |
Countries
Korea, Republic of
Contacts
Public ContactEun-Ki Min
Yonsei University Health System, Severance Hospital
Outcome results
None listed