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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentro Hospitalar de Lisboa Central

About this trial

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.

Eligibility criteria

Qualifiers

Hepatocellular carcinoma associated with cirrhosis

Ages between 18 and 70 years

Total tumour volume below 500 cm3

Total number of tumour lesions below 10

Disqualifiers

eligible under the "Milan Criteria"

Trial design

Treatments tested in this trial

  • liver transplant

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Centro Hospitalar de Lisboa Central

Lead sponsor

Ophiomics - Precision Medicine

Collaborator