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HOPE perfusion to reduce liver cancer coming back after transplant

Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT

Phase 4 Interventional Clarunis - Universitäres Bauchzentrum Basel · NCT06717919

This trial tests whether treating donor livers with hypothermic oxygenated perfusion (HOPE) before transplant helps people with hepatocellular carcinoma (HCC) have less cancer recurrence and better survival.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment220 (estimated)
Ages18 Years and up
SexAll
SponsorClarunis - Universitäres Bauchzentrum Basel Academic / other
Locations37 sites (New York, New York and 36 other locations)
Trial IDNCT06717919 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults listed for liver transplantation with confirmed HCC within up-to-seven criteria who can give informed consent and are eligible for a standard whole-donor graft.

Not a fit: Patients receiving DCD grafts, combined or partial liver transplants, those with mixed hepatocellular-cholangiocarcinoma or other excluded tumor types, or those on systemic checkpoint or mTOR inhibitor therapies are unlikely to be included or to benefit from this intervention.

Why it matters

Potential benefit: If successful, HOPE could lower rates of tumor recurrence and improve long-term survival after liver transplant for HCC.

How similar studies have performed: Prior clinical studies show HOPE can improve graft function and reduce biliary complications, but evidence that perfusion lowers cancer recurrence after transplant is limited and this trial aims to fill that gap.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

New York, New York and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Liver TransplantationHCCOncological OutcomesHOPErandomised controlled trialmulticentrehepatocellular carcinomaliver transplantation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.