HepatoPredict Prognostic Tool for the Decision of Liver Transplant in Hepatocellular Carcinoma

Liver transplant is the most effective treatment for hepatocellular carcinoma (HCC) in cirrhosis. Due to organs shortage, the proper selection of patients is imperative. Prevailing clinical morphological models used in most centres (Milan Criteria), can exclude potential candidates and include patients with aggressive biological behaviour. To more accurately select candidates for liver transplant, the inclusion of criteria that could predict the behaviour and aggressiveness of tumours, such as molecular markers, might be useful. The investigators propose the use of a new algorithm (HepatoPredict Prognostic Tool), that combine clinical and molecular criteria that address the biology of tumours, in a single centre prospective, intervention study. Data from the "HepatoPredict genomic signature" are added to the clinical and imagiology algorithm. Based on this tool, patients outside the usual eligibility criteria for liver transplant will be proposed for this treatment. These patients will be transplanted with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy, not competing with patients on the waiting list. Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening. Survival and disease-free-survival rates will be compared with those obtained by the usual management of patients included and excluded by Milan Criteria.

NCT Number	NCT04499833
Lead Sponsor	Centro Hospitalar de Lisboa Central Collaborators: Ophiomics - Precision Medicine
Conditions	Hepatocellular Carcinoma, Scirrhous, Recurrence Tumor
Enrollment	40 participants
Start Date	2021-03-25
Primary Completion	2028-10-30 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2022-06-06