Tests a new tool to guide liver transplant choice in liver cancer
Tests a tool that picks liver cancer patients for transplant beyond usual criteria.
Key facts
- Who runs it
- Centro Hospitalar de Lisboa Central
- Where
- Lisbon, PortugalSee the site
- Trial code
- Registry title
- HepatoPredict Prognostic Tool for the Decision of Liver Transplant in Hepatocellular Carcinoma
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 25 Mar 2021
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional
- Treatments tested
- liver transplant
- Record updated
- 6 June 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with hepatocellular carcinoma (liver cancer) and cirrhosis whose tumours fall outside the usual Milan Criteria. They would be assessed for a liver transplant.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Hepatocellular carcinoma with cirrhosis. Total tumour volume below 500 cm3, fewer than 10 tumour lesions, and each tumour below 10 cm (3.9 in) across.
- Biomarker or test result
- The HepatoPredict genomic signature is used together with clinical and imaging data to decide on transplant.
Main reasons for not taking part
- People who qualify under the Milan Criteria cannot join.
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- eligible under the "Milan Criteria"
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in Portugal
- Centro Hepato-bilio-pancreático e de Transplantação do Hospital Curry CabralLisbon, PortugalContact: Hugo Pinto-Marques, MD PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- liver transplant outside the "Milan Criteria"Treatment being tested
patients with hepatocellular carcinoma, outside the "Milan Criteria", that complied with the proposed HepatoPredictTool, submitted to liver transplant
Treatment: liver transplant
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of the HepatoPredict Prognostic Tool in the Decision of Liver Transplant in Hepatocellular Carcinoma
- Plain-language title
- Tests a new tool to guide liver transplant choice in liver cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04499833, who can take part
- Record updated
- 6 June 2022