Liver Transplant for Hepatocellular Carcinoma

NCT07629193 | Not Yet Recruiting

• 1 other identifier: APHP251223
• Study Type: observational
• Target: 562
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research focuses on analysing data collected as part of your usual care. Currently, the eligibility of patients with hepatocellular carcinoma for liver transplantation is based on the calculation of scores. These scores mainly take into account the volume of the tumour measured by imaging, one or more blood markers and the patient's general condition. However, these scores do not take into account:

• the concept of downstaging (i.e. the prior reduction of tumour volume through locoregional or systemic treatments, which subsequently allows access to LT), which is becoming increasingly widespread
• the dynamics of hepatocellular carcinoma (tumour recurrence while waiting on the transplant list, administration of wait-and-see treatments)
• certain anatomopathological parameters (such as the macro-trabecular subtype of HCC). The aim of our study is to develop a new score incorporating these factors in order to identify patients with hepatocellular carcinoma who could truly benefit from a liver transplant. To answer the question posed in the research, data will be collected from 402 people who received a liver transplant for hepatocellular carcinoma at three hospitals in the Paris region between 1 January 2018 and 31 December 2023, and from 160 people at two international hospitals in Canada and Belgium.

Conditions

Hepatocellular Carcinoma (HCC); Liver Transplantation (LT)

Keywords

predictive score; Liver Transplantation (LT)

Outcome Measures

Primary Outcomes (1)

• Failure of liver transplantation (LT)

  Failure of LT is defined as the occurrence of one of the following events: (i) removal from the transplant waiting list, (ii) recurrence of HCC post-LT, or (iii) death.

  Up to 7 years after LT

Secondary Outcomes (4)

• Overall survival

  Up to 7 years after LT

• Recurrence-free survival

  Up to 7 years after LT

• Occurrence of acute cellular rejection

  Up to 7 years after LT

• Correlation of LT failure rate, overall survival and recurrence-free survival with biological, clinical, imaging and anatomopathological parameters (macro-trabecular subtype) at enrolment and on the day of LT

  Up to 7 years after LT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will retrospectively include patients who underwent LT for HCC between 1 January 2018 and 31 December 2023 in the Paris, Montreal and Brussels centres. The derivation cohort will include patients from the AP-HP, while the validation cohort will include patients from the centres in Montreal and Brussels.

You may qualify if:

• Adults (≥18 years).
• Underwent LT for HCC between January 1, 2018 and December 31, 2023.

You may not qualify if:

• No evidence of HCC (imaging or histology).
• LT performed for another intrahepatic tumor other than HCC.
• The patient's objection to the use of their data.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Erasme University Hospital: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Manon Allaire, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

• Héloïse Giudicelli, MD

  Sorbonne University, Paris, France

  STUDY DIRECTOR

Central Study Contacts

Manon Allaire, MD

CONTACT

+33 1 42 16 10 34; manon.allaire@aphp.fr

Héloïse Giudicelli, MD

CONTACT

heloise.giudicelli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06