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Background <p>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.</p> Methods <p>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&#xa0;h and perfusion is generally continued until the recipient hepatectomy is completed. The conventional cold storage at 4&#xa0;°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.</p> Discussion <p>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.</p> Trial registration <p>ClinicalTrials.gov NCT06717919. Registered on December 5, 2024.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月26日

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  • Janina Eden,
  • Philip C. Müller,
  • Christoph Kuemmerli,
  • Florian Peters,
  • Tanja Litke,
  • Anne Kranich,
  • Andreas E. Kremer,
  • Stefanie von Felten,
  • Philipp Dutkowski,
  • Vincent E de Meijer,
  • Lutz Fischer,
  • Umberto Cillo,
  • Riccardo De Carlis,
  • Vincenzo Mazzaferro,
  • Robert J Porte,
  • Jacques Pirenne,
  • Andrea Schlegel,
  • James V Guarrera,
  • Gabriela Berlakovich,
  • Jiri Fronek,
  • Georg Lurje,
  • Jens Mittler,
  • Moritz Drefs,
  • Philippe Compagnon,
  • Miriam Cortes-Cerisuelo,
  • Joerg M Pollok,
  • Barbara Fiore,
  • Rebeca Sanabria-Mateos,
  • Christoph Tschuor,
  • Cornelius van Beekum,
  • Ulf P Neumann,
  • Gabriel C Oniscu,
  • Povilas Ignatavicius,
  • Xavier Muller,
  • Diethard Monbaliu,
  • Stefan Schneeberger,
  • Piotr Domagala,
  • Pål-Dag Line,
  • Umberto Baccarani,
  • Eliano Bonaccorsi,
  • Rodrigo Figueiredo,
  • Philipp Kron

摘要

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.