Status:
NOT_YET_RECRUITING
Adjuvant Everolimus in High-Risk Hepatocellular Carcinoma After Curative Resection (SEVERANCE Trial)
Lead Sponsor:
Yonsei University
Conditions:
Carcinom
Hepatocellular
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
"Hepatic resection is the primary curative treatment for patients with a single, liver-confined hepatocellular carcinoma (HCC) without cirrhosis and is also considered in patients with cirrhosis if re...
Eligibility Criteria
Inclusion
- 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) \< 30 mL/min/1.73m² (based on MDRD formula)
- Total cholesterol \> 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.
Exclusion
- 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) \< 1500/μL or platelet count \< 75,000/μL
- AST, ALT, or total bilirubin levels \> 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) \< 30 mL/min/1.73m² (based on MDRD formula)
- Total cholesterol \> 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2030
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06972758
Start Date
July 1 2025
End Date
July 30 2030
Last Update
May 15 2025
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