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

Recurrence Tumor Clinical Trial

— HepatoPredict  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499833
• Other study ID #: CHULC.CI.HCC.2020
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: December 31, 2029

Study information

• Verified date: June 2022
• Source: Centro Hospitalar de Lisboa Central
• Contact: Hugo Pinto-Marques, MD PhD
• Phone: +351917302214
• Email: hugo.marques3[@]chlc.min-saude.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2029
• Est. primary completion date: October 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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"

Related Conditions & MeSH terms

• Adenocarcinoma, Scirrhous
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma, Scirrhous
• Recurrence
• Recurrence Tumor

Intervention

Procedure:
• liver transplant
liver transplant

Locations

Country	Name	City	State
Portugal	Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar de Lisboa Central	Ophiomics - Precision Medicine

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death by any cause	from 6 months after liver transplant up to 60 months
Primary	hepatocellular carcinoma recurrence	identification of hepatocellular carcinoma recurrence through biannual triphasic CT scan	from 6 months after liver transplant up to 60 months
Secondary	hepatocellular carcinoma recurrence through liquid biopsy	early identification of hepatocellular carcinoma DNA through biannual serum samples (liquid biopsy)	from 6 months after liver transplant up to 60 months