HOPE perfusion to reduce liver cancer coming back after transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter phase 4 trial compares hypothermic oxygenated perfusion (HOPE) of donor livers versus conventional cold storage in adult patients undergoing liver transplantation for hepatocellular carcinoma (HCC). Eligible participants are adults with confirmed HCC who meet up-to-seven criteria and who consent to randomization to a perfused or non-perfused graft. Key exclusions include donation after circulatory death (DCD) grafts, combined or partial transplants, certain tumor histologies, and patients receiving checkpoint inhibitors or mTOR inhibitors. Participating centers in the US and Austria will enroll patients and follow oncological outcomes including recurrence and survival over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult recipients (\>18y), listed for liver transplantation with documented HCC (Liver Imaging Reporting and Data System (LIRADS) 5 lesion in magnetic resonance imaging or computer tomography of the liver or biopsy proven),
* within up to seven criteria, i.e. HCC with seven as the sum of the diameter of the largest tumour (in cm) and the number of tumours at the time point of liver transplantation,
* written informed consent for the trial. This also includes patients beyond the up to seven criteria after successful downsizing of the HCC

Exclusion Criteria:

* Donation after circulatory death (DCD) liver grafts
* Combined liver transplants
* Partial liver transplants
* Combined or mixed hepatocellular cholangiocarcinoma (cHCC-CCC) or pure cholangiocarcinoma or other malignancies in histopathology of the liver explant
* Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors
* Post-transplant treatment with mTOR inhibitors
* Acute and unexpected medical contraindications
* Pregnancy
* Cold storage time of \> 10 hours (both study arms)

Where it's running

• Medical University of Innsbruck
  Innsbruck, Austria Recruiting
• Medical University of Vienna
  Vienna, Austria Recruiting
• University Hospitals Leuven
  Leuven, Belgium Recruiting
• Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
  Woluwe-Saint-Lambert, Belgium Recruiting
• Institute for Clinical and Experimental Medicine (IKEM) (Prague)
  Prague, Czechia Recruiting
• Copenhagen University Hospital
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Philipp Dutkowski, Professor
• Email: philipp.dutkowski@clarunis.ch
• Phone: 0041 61 777 73 06

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.