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NCT06717919RecruitingPhase 4

HOPE Against Cancer Recurrence in HCC

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

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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 recurrence is improved when the liver is perfused before implantation. The study involves transplant centers worldwide, and adults with HCC waiting for liver transplantation are included. 220 Patients will be recruited within 12 months and then observed for at least 2 years after transplantation. To provide the most valid results, the patients will be randomly allocated to either the organ perfusion group or a control group with standard-of-care cold storage of the organ.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
220 (estimated)
First submitted
27 Nov 2024
Start date
1 Aug 2025
Primary completion date
31 Jan 2028
Lead sponsor
Philipp Dutkowski
NCT number
NCT06717919

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 220
  • From 1 Aug 2025 to the primary completion date, 31 Jan 2028
  • 37 sites in 17 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Systemic antitumoural medical treatment with checkpoint inhibitors or multikinase inhibitors
  • Post-transplant treatment with mTOR inhibitors

Other illness

  • Combined or mixed hepatocellular cholangiocarcinoma (cHCC-CCC) or pure cholangiocarcinoma or other malignancies in histopathology of the liver explant

Other

  • Donation after circulatory death (DCD) liver grafts
  • Combined liver transplants
  • Partial liver transplants
  • Acute and unexpected medical contraindications
  • Pregnancy
  • Cold storage time of \> 10 hours (both study arms)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Innsbruck
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InnsbruckAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
University Hospitals Leuven
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LeuvenBelgiumRecruiting
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
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Woluwe-Saint-LambertBelgiumRecruiting
Clarunis - University Digestive Health Care
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BaselSwitzerlandNot yet recruiting
Hôpitaux universitaires de Genève
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GenevaSwitzerlandRecruiting
University Hospital Zurich
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ZurichSwitzerlandNot yet recruiting
Institute for Clinical and Experimental Medicine (IKEM) (Prague)
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PragueCzechiaRecruiting
Universitätsklinikum Essen
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EssenGermanyNot yet recruiting
University Medical Centre Hamburg-Eppendorf
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Hamburg-EppendorfGermanyNot yet recruiting
Hannover Medical School
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HanoverGermanyNot yet recruiting
University of Heidelberg
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HeidelbergGermanyNot yet recruiting
University of Mainz
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MainzGermanyNot yet recruiting
University of Munich Grosshadern
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MünchenGermanyNot yet recruiting
Copenhagen University Hospital
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CopenhagenDenmarkRecruiting
Vall d'Hebron Barcelona Hospital Campus
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BarcelonaSpainNot yet recruiting
Hôpital de la Croix-Rousse (Lyon)
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LyonFranceNot yet recruiting
University Hospitals Birmingham
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BirminghamUnited KingdomNot yet recruiting
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomNot yet recruiting
King's College Hospital (London)
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LondonUnited KingdomNot yet recruiting
The Royal Free Hospital (London)
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LondonUnited KingdomNot yet recruiting
Freeman Hospital, Newcastle
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NewcastleUnited KingdomNot yet recruiting
ASST Grande Ospedale Metropolitano Niguarda (Milan)
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MilanItalyNot yet recruiting
Milano Institutio Nazionale dei Tumori (Milan)
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MilanItalyNot yet recruiting
Padova University Hospital
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PadovaItalyNot yet recruiting
Gemelli University Hospital
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RomeItalyNot yet recruiting
University of Udine
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UdineItalyRecruiting
Lithuanian University of Health Sciences
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KaunasLithuaniaNot yet recruiting
University of Groningen and University Medical Centre Groningen
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GroningenNetherlandsNot yet recruiting
University Medical Centre Rotterdam - Erasmus University Medical Center
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RotterdamNetherlandsNot yet recruiting
Oslo University Hospital
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OsloNorwayNot yet recruiting
Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk
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GdanskPolandRecruiting
Medical University of Warsaw
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WarsawPolandNot yet recruiting
Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)
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LisbonPortugalNot yet recruiting
Karolinska Institutet (Stockholm)
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StockholmSwedenRecruiting
Cleveland Clinic
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ClevelandUnited StatesNot yet recruiting
Rutgers New Jersey Medical School (New York)
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New YorkUnited StatesNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.