None listed
Conditions
Interventions
Drug : Following initial standard immunosuppressive therapy, treatment is switched to or augmented with an everolimus-containing regimen between 4 and 8 weeks post-liver transplantation.
Everolimus
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 and over, but under 80 2) Patients who are able to voluntarily sign a written informed consent form 3) Patients diagnosed with hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) or European Association for the Study of the Liver (EASL) guidelines, and who are candidates for liver transplantation (from a deceased or living donor) 4) Patients with confirmed 18F-FDG-avid HCC (Tumor SUVmax/Liver SUVmax >= 1.15) at least once on 18F-FDG PET/CT within 3 months prior to the scheduled liver transplantation date 5) Patients with confirmed viable HCC (LR-5 or LR-TR-V lesion) on liver CT or MRI within 1 month prior to the scheduled liver transplantation date 6) Patients who are capable of understanding and following instructions and who can participate for the entire duration of the study schedule
Exclusion criteria
Exclusion criteria: 1) Patients with confirmed macrovascular tumor thrombosis or extrahepatic metastasis at any time since the diagnosis of hepatocellular carcinoma (HCC) (including cases confirmed by explant histopathology after liver transplantation) 2) Patients diagnosed with extrahepatic malignancy within 5 years prior to study participation (except for non-melanoma skin cancer [basal cell carcinoma, squamous cell carcinoma] and carcinoma in situ [e.g., cervical carcinoma in situ, ductal carcinoma in situ, etc.] that have been completely cured with appropriate treatment and show no evidence of current recurrence) 3) Patients scheduled for ABO-incompatible liver transplantation 4) Patients with no viable HCC confirmed on explant histopathology after liver transplantation, or those with combined HCC/cholangiocarcinoma (CCA) 5) Patients with confirmed recurrence of HCC prior to the initiation of everolimus 6) Patients with a history of hypersensitivity or allergic reactions to everolimus, other mTOR inhibitors, or lactose 7) Patients requiring continuous administration of potent CYP3A4 inhibitors or inducersPatients who received systemic chemotherapy for HCC prior to liver transplantation 8) Patients with uncontrolled comorbidities, such as diabetes mellitus, dyslipidemia, or hypertension, despite appropriate medical therapy 9) Recipients of organ transplants other than the liver 10) Pregnant or lactating women 11) Patients with an ECOG performance status of 2 or higher at the time of everolimus initiation 12) Patients with a urine protein-to-creatinine ratio (UPCR) >=1.0 mg/mg on urinalysis, or an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (MDRD equation) 13) Patients with severe cardiovascular or cerebrovascular disease, or those deemed unsuitable for study participation by the principal investigator (or sub-investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year recurrence free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and proportion of Adverse Events (AEs);Recurrence-Free Survival (RFS);Time to Recurrence (TTR);Overall Survival (OS);Adverse Drug Reactions (ADRs);Serious AEs/ADRs;Change from baseline in Quality of Life (QoL) indices (EQ-5D-5L and EORTC QLQ-C30), and Time to Definitive Deterioration (TUDD) of global health status/QoL and functional scales on the EORTC QLQ-C30 | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Won Chung
Asan Medical Center
Outcome results
None listed