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

NCT04499833 | Recruiting

• 1 other identifier: CHULC.CI.HCC.2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma, Scirrhous; Recurrence Tumor

Keywords

cirrhosis; Hepatocellular Carcinoma; liver transplant; tumor recurrence; biomarkers; prognosis

Outcome Measures

Primary Outcomes (2)

• death

  death by any cause

  from 6 months after liver transplant up to 60 months

• hepatocellular carcinoma recurrence

  identification of hepatocellular carcinoma recurrence through biannual triphasic CT scan

  from 6 months after liver transplant up to 60 months

Secondary Outcomes (1)

• hepatocellular carcinoma recurrence through liquid biopsy

  from 6 months after liver transplant up to 60 months

Study Arms (1)

liver transplant outside the "Milan Criteria"

EXPERIMENTAL

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

Procedure: liver transplant

Interventions

liver transplant PROCEDURE

liver transplant

liver transplant outside the "Milan Criteria"

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• eligible under the "Milan Criteria"

Sponsors & Collaborators

• Centro Hospitalar de Lisboa Central: lead
• Ophiomics - Precision Medicine: collaborator

Study Sites (1)

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

Lisbon, 1069-166, Portugal

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence; Fibrosis

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Hugo Pinto-Marques, MD PhD

  Centro Hospitalar Universitário de Lisboa Central

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo Pinto-Marques, MD PhD

CONTACT

+351917302214; hugo.marques3@chlc.min-saude.pt

Sílvia Gomes-da-Silva, MD

CONTACT

+351916876393; silvia.silva@chlc.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective evaluation of patients with hepatocellular carcinoma in cirrhotic liver, outside the "Milan Criteria" for liver transplant, that comply with the morphologic criteria stablished for the proposed HepatoPredict Tool: (1) Total tumour volume below 500 cm3; (2) Total number of tumour lesions below 10; and (3) maximum individual tumour diameter below 10 cm. Those patients are proposed to be submitted to molecular study of the hepatocellular carcinoma and, if comply with the "HepatoPredict genomic signature", liver transplantation will be proposed. Patients will be followed up for up to 5 years after transplantation for survival and survival-free-of-disease.

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: March 25, 2021
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)