NCT04499833: HepatoPredict

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

Recruiting now NA Last updated 6 June 2022

What this trial tests

NA trial testing liver transplant in Hepatocellular Carcinoma, Scirrhous in 40 participants. Currently enrolling.

Timeline

25 March 2021

Primary endpoint
30 October 2028

31 December 2029

Quick facts

Lead sponsor	Centro Hospitalar de Lisboa Central
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	25 March 2021
Primary completion	30 October 2028
Estimated completion	31 December 2029
Sites	1 location across Portugal

Drugs / interventions tested

• liver transplant

Conditions studied

• Hepatocellular Carcinoma, Scirrhous — all drugs for Hepatocellular Carcinoma, Scirrhous →
• Recurrence Tumor — all drugs for Recurrence Tumor →

Sponsor

Centro Hospitalar de Lisboa Central

Who can join

Adults 18 to 70, any sex, with Hepatocellular Carcinoma, Scirrhous or Recurrence Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Gene Expression Signature to Select Hepatocellular Carcinoma Patients for Liver Transplantation.
   Pinto-Marques H, Cardoso J, Silva S, Neto JL, et al · · 2022 · cited 14× · PMID 35916378 · DOI 10.1097/sla.0000000000005637
2. HepatoPredict Accurately Selects Hepatocellular Carcinoma Patients for Liver Transplantation Regardless of Tumor Heterogeneity.
   Andrade R, Perez-Rojas J, da Silva SG, Miskinyte M, et al · · 2025 · PMID 39941867 · DOI 10.3390/cancers17030500