Observational Not yet recruiting
NCT07629193 on ClinicalTrials.gov
Liver Transplant for Hepatocellular Carcinoma
- Sponsor: Assistance Publique - Hôpitaux de Paris
- Collaborators: Centre hospitalier de l'Université de Montréal (CHUM), Erasme University Hospital
- Enrollment: 562 (Estimated)
- Study start: 2026-06-01 (Estimated)
- Primary completion: 2027-01-01 (Estimated)
- Study completion: 2027-01-01 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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)
Primary Outcome Measures
-
Failure of liver transplantation (LT)
(Up to 7 years after 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.
Study Officials
- Manon Allaire, MD (Study Chair) — Assistance Publique - Hôpitaux de Paris
- Héloïse Giudicelli, MD (Study Director) — Sorbonne University, Paris, France