Hypothermic oxygenated perfusion (HOPE) against cancer recurrence after liver transplantation for hepatocellular carcinoma-study protocol for an international multicenter randomized controlled trial (HOPE4Cancer).

Publication/Presentation Date

9-26-2025

Abstract

BACKGROUND: A frequent and increasing indication for liver transplantation (LT) is hepatocellular carcinoma (HCC). However, despite strict selection criteria, HCC recurrence after LT occurs in a relevant proportion of patients and is associated with an unfavorable prognosis. Hypothermic oxygenated perfusion (HOPE) is a novel machine liver perfusion approach to optimize liver grafts before implantation and has been suggested to decrease graft inflammation with potential anti-cancer effects.

METHODS: HOPE4Cancer is an international, multicentric, parallel group, randomized controlled trial comparing HOPE performed after initial cold storage (intervention) with conventional cold storage alone (control) in a 1:1 allocation ratio. Adult recipients with proven HCC will be included for transplantation of a DBD (donation after brain death) Liver graft. The minimum perfusion duration is defined at 2 h and perfusion is generally continued until the recipient hepatectomy is completed. The conventional cold storage at 4 °C will be performed with a precooled preservation solution according to the local standard of care. The primary endpoint is defined as post-transplant HCC recurrence-free survival, i.e., the time interval a patient is alive without HCC recurrence after transplantation. Secondary endpoints are the single components of the events considered for the primary outcome (i.e., HCC recurrence, HCC-related death, death from any other causes than HCC), circulating tumor DNA, high-mobility-group-protein B1 in the blood, the Rejection Activity index, and the number of liver-related complications experienced by the patient.

DISCUSSION: HOPE4Cancer investigates if cold storage plus end-ischemically applied HOPE in DBD LT is superior to conventional cold storage of liver grafts in terms of post-transplant HCC recurrence-free survival. The results will indicate for the first time whether ex situ HOPE before transplant has an anti-cancer potential compared to transplantation of un-perfused livers.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06717919. Registered on December 5, 2024.

Volume

26

Issue

1

First Page

369

Last Page

369

ISSN

1745-6215

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

41013675

Department(s)

Administration and Leadership

Document Type

Article

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