HOPE Against Cancer Recurrence in HCC

This study is looking at a new way to prepare donor livers for transplant in patients with hepatocellular carcinoma (HCC), a type of liver cancer. The goal is to see if a method called hypothermic oxygenated perfusion (HOPE) can reduce the chance of cancer coming back after a liver transplant. HOPE involves perfusing (flushing) the donor liver with an oxygen-rich fluid in a cold environment before it's transplanted. This is compared to the standard method of just cold storage. You might be able to join if you are an adult (over 18) and are scheduled for a liver transplant due to HCC, meeting specific tumor criteria. The study will measure how long patients live without their cancer returning, specifically at 24 months after transplant. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 220 participants. It compares two methods of preparing donor livers: hypothermic oxygenated perfusion (HOPE) and conventional cold storage.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, recurrence-free survival, will be measured at 24 months after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06717919

HOPE Against Cancer Recurrence in HCC

Recruiting
PHASE4Ages 18+InterventionalTreatment
Philipp Dutkowski
~220 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:Hypothermic oxygenated perfusionConventional cold storage

At a glance

Recruiting sites
10 of 37 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence free survival
Measured over 24 months
Liver Transplantation
HCC
Oncological Outcomes

NCT06717919

Where you'd take part

This study runs at 37 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ASST Grande Ospedale Metropolitano Niguarda (Milan)

    Milan, Italystudy coordinator listed

    Not yet recruiting

  • Clarunis - University Digestive Health Care

    Basel, Canton of Basel-City, Switzerlandstudy coordinator listed

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Not yet recruiting

  • Copenhagen University Hospital

    Copenhagen, Denmarkstudy coordinator listed

    Recruiting

  • Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk

    Gdansk, Polandstudy coordinator listed

    Recruiting

  • Freeman Hospital (Newcastle)

    Newcastle, United Kingdomstudy coordinator listed

    Not yet recruiting

  • Gemelli University Hospital

    Rome, Italystudy coordinator listed

    Not yet recruiting

  • Hannover Medical School

    Hanover, Germanystudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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)
  • Recurrence free survival24 months

    Post transplant HCC recurrence free survival, i.e. the time interval a patient is alive without HCC recurrence after transplantation, i.e., until either HCC recurrence is observed, or the patient dies from any cause.