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

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ClinicalTrials.gov Identifier: NCT04499833
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : June 6, 2022
Sponsor:
Collaborator:
Ophiomics - Precision Medicine
Information provided by (Responsible Party):
Centro Hospitalar de Lisboa Central

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma, Scirrhous Recurrence Tumor Procedure: liver transplant Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma
Actual Study Start Date : March 25, 2021
Estimated Primary Completion Date : October 30, 2028
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: liver transplant outside the "Milan Criteria"
patients with hepatocellular carcinoma, outside the "Milan Criteria", that complied with the proposed HepatoPredictTool, submitted to liver transplant
 Procedure: liver transplant
liver transplant


Outcome Measures
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Primary Outcome Measures :
  1. death [ Time Frame: from 6 months after liver transplant up to 60 months ]
    death by any cause

  2. hepatocellular carcinoma recurrence [ Time Frame: from 6 months after liver transplant up to 60 months ]
    identification of hepatocellular carcinoma recurrence through biannual triphasic CT scan


Secondary Outcome Measures :
  1. hepatocellular carcinoma recurrence through liquid biopsy [ Time Frame: from 6 months after liver transplant up to 60 months ]
    early identification of hepatocellular carcinoma DNA through biannual serum samples (liquid biopsy)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499833


Contacts
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Contact: Hugo Pinto-Marques, MD PhD +351917302214 hugo.marques3@chlc.min-saude.pt
Contact: Sílvia Gomes-da-Silva, MD +351916876393 silvia.silva@chlc.min-saude.pt

Locations
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Portugal
Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry Cabral Recruiting
Lisboa, Portugal, 1069-166
Contact: Hugo Pinto-Marques, MD PhD    +351917302214    hugo.marques3@chlc.min-saude.pt   
Contact: Luis Pereira-de-Silva, MD PhD    +351213596402 ext 51402    centro.investigacao@chlc.min-saude.pt   
Sub-Investigator: Sílvia Gomes-da-Silva, MD         
Sub-Investigator: Jose Pereira-Leal, PhD         
Sponsors and Collaborators
Centro Hospitalar de Lisboa Central
Ophiomics - Precision Medicine
Investigators
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Principal Investigator: Hugo Pinto-Marques, MD PhD Centro Hospitalar Universitário de Lisboa Central
More Information
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Responsible Party: Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT04499833    
Other Study ID Numbers: CHULC.CI.HCC.2020
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centro Hospitalar de Lisboa Central:
cirrhosis
Hepatocellular Carcinoma
liver transplant
 tumor recurrence
biomarkers
prognosis
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma, Scirrhous
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Disease Attributes
Pathologic Processes