Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT06972758
Eligibility Criteria:
Inclusion Criteria:
* 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 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) \< 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT06972758
Study Brief:
Protocol Section:
NCT06972758