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HOPE Against Cancer Recurrence in HCC

RecruitingPhase 4Ages 18 Years - anyAllPhilipp Dutkowski
NCT06717919 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Liver transplantation is often performed to treat liver cancer, or hepatocellular carcinoma (HCC), in patients with impaired liver function due to cirrhosis. A shortcoming, however, is tumor recurrence after transplantation. Approximately 15 % of patients receiving livers develop recurrence and this depends on the quality of the liver received. Machine liver perfusion, for example, hypothermic oxygenated liver perfusion (HOPE), which means that the organ is perfused with an oxygen-rich fluid in a cold environment before transplantation, is a novel method to improve the quality of livers before implantation. The standard of care is cold storage without perfusion. The objective of this study is to compare the survival after tumor recurrence of patients after liver transplantation for HCC between perfused and not perfused livers. This study's hypothesis is that survival without tumor recu

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📋 Eligibility rules (as published)
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)
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What it tests

  • Hypothermic oxygenated perfusion
  • Conventional cold storage
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Where

37 sites
Rutgers New Jersey Medical School (New York)
New York, United States
Cleveland Clinic
Cleveland, United States
Medical University of Innsbruck
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
University Hospitals Leuven
Leuven, Belgium
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
Woluwe-Saint-Lambert, Belgium
Institute for Clinical and Experimental Medicine (IKEM) (Prague)
Prague, Czechia
Copenhagen University Hospital
Copenhagen, Denmark

…and 29 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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