Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
220 participants
INTERVENTIONAL
2025-08-01
2028-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Conventional cold storage
Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.
Conventional cold storage
Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.
Hypothermic oxygenated perfusion
All study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation.
The perfusion devices are routinely used in all participating centres (VitaSmart, Bridge to Life®, Liver Assist, XVIVO®, Perlife, Aferitica®).
Hypothermic oxygenated perfusion
All study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation. The perfusion devices are routinely used in all participating centres.
Interventions
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Hypothermic oxygenated perfusion
All study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation. The perfusion devices are routinely used in all participating centres.
Conventional cold storage
Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Philipp Dutkowski
OTHER
Responsible Party
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Philipp Dutkowski
Sponsor representative and Principal Investigator
Locations
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Rutgers New Jersey Medical School (New York)
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, 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
Hôpital de la Croix-Rousse (Lyon)
Lyon, , France
Universitätsklinikum Essen
Essen, , Germany
University Medical Centre Hamburg-Eppendorf
Hamburg-Eppendorf, , Germany
Hannover Medical School
Hanover, , Germany
University of Heidelberg
Heidelberg, , Germany
University of Mainz
Mainz, , Germany
University of Munich Grosshadern
München, , Germany
Milano Institutio Nazionale dei Tumori (Milan)
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda (Milan)
Milan, , Italy
Padova University Hospital
Padua, , Italy
Gemelli University Hospital
Rome, , Italy
University of Udine
Udine, , Italy
Lithuanian University of Health Sciences
Kaunas, , Lithuania
University of Groningen and University Medical Centre Groningen
Groningen, , Netherlands
University Medical Centre Rotterdam - Erasmus University Medical Center
Rotterdam, , Netherlands
Oslo University Hospital
Oslo, , Norway
Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk
Gdansk, , Poland
Medical University of Warsaw
Warsaw, , Poland
Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)
Lisbon, , Portugal
Vall d'Hebron Barcelona Hospital Campus
Barcelona, , Spain
Karolinska Institutet (Stockholm)
Stockholm, , Sweden
Clarunis - University Digestive Health Care
Basel, Canton of Basel-City, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Hôpitaux universitaires de Genève
Geneva, , Switzerland
University Hospitals Birmingham
Birmingham, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
The Royal Free Hospital (London)
London, , United Kingdom
King's College Hospital (London)
London, , United Kingdom
Freeman Hospital (Newcastle)
Newcastle, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Hugo Pinto Marques, Prof
Role: primary
References
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Eden J, Muller PC, Kuemmerli C, Peters F, Litke T, Kranich A, Kremer AE, von Felten S, Dutkowski P; HOPE4Cancer Trial Investigators. Hypothermic oxygenated perfusion (HOPE) against cancer recurrence after liver transplantation for hepatocellular carcinoma-study protocol for an international multicenter randomized controlled trial (HOPE4Cancer). Trials. 2025 Sep 26;26(1):369. doi: 10.1186/s13063-025-09120-1.
Other Identifiers
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221622
Identifier Type: -
Identifier Source: org_study_id