NCT05276037

Value of Negative 18FDG PET/CT in Milan Out, Up-to-seven in, HCC Transplant Candidates

Recruiting now Last updated 1 September 2022

What this trial tests

trial testing Liver transplantation in Hepatocellular Carcinoma in 350 participants. Currently enrolling.

Timeline

1 January 2019

Primary endpoint
1 January 2025

1 January 2029

Quick facts

Lead sponsor	University of Liege
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	350
Start date	1 January 2019
Primary completion	1 January 2025
Estimated completion	1 January 2029
Sites	6 locations across Belgium

Drugs / interventions tested

• Liver transplantation

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

University of Liege

Who can join

Adults 18 to 80, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatocellular carcinoma (HCC) is a rising public health concern with few curative options but liver transplantion (LT) in highly selected cases. LT could save many other HCC patients but organ shortage has lead to the necessity of selection of patients with the best survival chances, namely the Milan criteria. Hepatocellular carcinoma (HCC) is the fifth most common cancer, and the third cause of cancer related-death worldwide. HCC incidence is rising in Western countries including Belgium. There are more than 1,000 new HCC diagnoses in Belgium every year, but only 90 to 100 patients suffering from HCC are listed for liver transplantation (LT). In fact, the scarcity of organ donors has forced the development of strict criteria to limit LT to patients who are likely to have excellent outcomes. The universally accepted LT criteria for HCC are the Milan criteria (1 HCC nodule ≤5 cm or 3 nodules ≤3cm) that lead to a low rate of post-LT recurrence (\>80% of disease free recurrence at 5 years). The majority of patients suffering from HCC outside the Milan criteria at the time of diagnosis is not eligible for LT and is therefore limited to palliative care. It is however considered that some of these patients with HCC outside the Milan criteria may benefit from LT with an acceptable risk of recurrence and chances of long-term disease-free survival (DFS). This fact has led to the extension of LT criteria for HCC in some centres in different countries, as for example the University of California San Francisco (UCSF) criteria, the up-to-seven criteria or the Asan criteria.

The Belgian Liver-Intestine Allocation Committee (Be-LIAC) is a section of the Belgian Transplantation Society (BTS) composed of the 6 LT Belgian centres in charge of coordinating deceased LT activity in Belgium with the help of Eurotransplant. Be-LIAC has already built a retrospective HCC database that was successfully used for several scientific studies allowing international presentations and publications. Based on this successful experience, Be-LIAC is keen to continue with this national collaboration to initiate a prospective clinical observational database to better study the results of LT in Belgium and to evaluate potential of extension of LT criteria in HCC patients. Inclusion in this database will not change patient management or the allocation process of the liver grafts in Belgium. This project is financed by a 4-year (2019-2022) grant of the Belgian "Fondation contre le cancer" / "Stichting tegen Kanker".

Publications & conference data

No peer-reviewed publications indexed yet for this trial.