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

NCT ID: NCT04499833

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2029-12-31

Brief Summary

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.

Detailed 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, Ophiomics), combining morphologic information, clinical and molecular criteria, in a prospective, intervention, single centre study.

Patients aged 18 to 70 years, with HCC in cirrhosis, not eligible for liver transplant under the "Milan Criteria", whom had the following morphologic characteristics: total tumour volume below 500 cm3, total number of tumour lesions below 10 and maximum individual tumour diameter below 10 cm, will be proposed for the "HepatoPredict genomic signature" analysis (Ophiomics), obtained from DNA of tumor samples. Those considered candidates by the algorithm are to be proposed for transplant with marginal livers or with livers from patients with Familial Amyloid Polyneuropathy.

Patients will be followed up to 60 months after transplant, to assess survival and HCC recurrence with biannual imagiology screening by triphasic CT scan. Additionally, circulating tumour DNA will be assessed previously to the transplant and biannually for up to 60 months. Survival and disease-free-survival rates will be compared with those obtained with the usual management of patients included and excluded by Milan Criteria, both in the same referral transplant center and in the published literature.

Conditions

Hepatocellular Carcinoma, Scirrhous; Recurrence Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

liver transplant outside the "Milan Criteria"

patients with hepatocellular carcinoma, outside the "Milan Criteria", that complied with the proposed HepatoPredictTool, submitted to liver transplant

Group Type: EXPERIMENTAL

liver transplant

Intervention Type: PROCEDURE

liver transplant

Interventions

liver transplant

liver transplant

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Hepatocellular carcinoma associated with cirrhosis
• Ages between 18 and 70 years
• Total tumour volume below 500 cm3
• Total number of tumour lesions below 10
• Maximum individual tumour diameter below 10 cm

Exclusion Criteria

• eligible under the "Milan Criteria"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ophiomics - Precision Medicine

UNKNOWN

Sponsor Role: collaborator

Centro Hospitalar de Lisboa Central

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugo Pinto-Marques, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Universitário de Lisboa Central

Locations

Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral

Lisbon, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Hugo Pinto-Marques, MD PhD

Role: CONTACT

hugo.marques3@chlc.min-saude.pt

+351917302214

Sílvia Gomes-da-Silva, MD

Role: CONTACT

silvia.silva@chlc.min-saude.pt

+351916876393

Facility Contacts

Hugo Pinto-Marques, MD PhD

Role: primary

hugo.marques3@chlc.min-saude.pt

+351917302214

Luis Pereira-de-Silva, MD PhD

Role: backup

centro.investigacao@chlc.min-saude.pt

+351213596402 ext. 51402

Other Identifiers

CHULC.CI.HCC.2020

Identifier Type: -

Identifier Source: org_study_id