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NCT06717919PHASE4Recruiting

HOPE Against Cancer Recurrence in HCC

Philipp Dutkowski

Start Date

8/1/2025

Completion Date

1/31/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

PROCEDURE

Hypothermic oxygenated perfusion

PROCEDURE

Conventional cold storage

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Conditions

Liver TransplantationHCCOncological Outcomes

Locations

Rutgers New Jersey Medical School (New York)

New York, New York 07103

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Medical University of Innsbruck

Innsbruck, 6020

Austria

Medical University of Vienna

Vienna, 1090

Austria

University Hospitals Leuven

Leuven, 3000

Belgium

Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)

Woluwe-Saint-Lambert, 1200

Belgium

Institute for Clinical and Experimental Medicine (IKEM) (Prague)

Prague, 14021

Czechia

Copenhagen University Hospital

Copenhagen, 2100

Denmark

Hôpital de la Croix-Rousse (Lyon)

Lyon, 69004

France

Universitätsklinikum Essen

Essen, 45122

Germany

University Medical Centre Hamburg-Eppendorf

Hamburg-Eppendorf, 20246

Germany

Hannover Medical School

Hanover, 30626

Germany

University of Heidelberg

Heidelberg, 69120

Germany

University of Mainz

Mainz, 55131

Germany

University of Munich Grosshadern

München, 81377

Germany

Milano Institutio Nazionale dei Tumori (Milan)

Milan, 20133

Italy

ASST Grande Ospedale Metropolitano Niguarda (Milan)

Milan, 20162

Italy

Padova University Hospital

Padova, 35128

Italy

Gemelli University Hospital

Rome, 00168

Italy

University of Udine

Udine, 33100

Italy

Lithuanian University of Health Sciences

Kaunas, 50009

Lithuania

University of Groningen and University Medical Centre Groningen

Groningen, 9713

Netherlands

University Medical Centre Rotterdam - Erasmus University Medical Center

Rotterdam, 3015

Netherlands

Oslo University Hospital

Oslo, 0450

Norway

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

Gdansk, 80-210

Poland

Medical University of Warsaw

Warsaw, 02-097

Poland

Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)

Lisbon, 1069-166

Portugal

Vall d'Hebron Barcelona Hospital Campus

Barcelona, 08035

Spain

Karolinska Institutet (Stockholm)

Stockholm, 17177

Sweden

Clarunis - University Digestive Health Care

Basel, Canton of Basel-City 4031

Switzerland

University Hospital Zurich

Zurich, Canton of Zurich 8091

Switzerland

Hôpitaux universitaires de Genève

Geneva, 1205

Switzerland

University Hospitals Birmingham

Birmingham, B15 2GW

United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, LS97TF

United Kingdom

The Royal Free Hospital (London)

London, NW3 2QG

United Kingdom

King's College Hospital (London)

London, SE5 9RS

United Kingdom

Freeman Hospital (Newcastle)

Newcastle, NE7 7DN

United Kingdom