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
- Diseases
- Liver and biliary tract cancer
- 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
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| University Hospitals Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels) Coordinator of this site? Confirm its status | Woluwe-Saint-Lambert | Belgium | Recruiting |
| Clarunis - University Digestive Health Care Coordinator of this site? Confirm its status | Basel | Switzerland | Not yet recruiting |
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| Institute for Clinical and Experimental Medicine (IKEM) (Prague) Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| University Medical Centre Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg-Eppendorf | Germany | Not yet recruiting |
| Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Not yet recruiting |
| University of Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Not yet recruiting |
| University of Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| University of Munich Grosshadern Coordinator of this site? Confirm its status | München | Germany | Not yet recruiting |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Vall d'Hebron Barcelona Hospital Campus Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hôpital de la Croix-Rousse (Lyon) Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| University Hospitals Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Not yet recruiting |
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Not yet recruiting |
| King's College Hospital (London) Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| The Royal Free Hospital (London) Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Freeman Hospital, Newcastle Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Not yet recruiting |
| ASST Grande Ospedale Metropolitano Niguarda (Milan) Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Milano Institutio Nazionale dei Tumori (Milan) Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Padova University Hospital Coordinator of this site? Confirm its status | Padova | Italy | Not yet recruiting |
| Gemelli University Hospital Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| University of Udine Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Lithuanian University of Health Sciences Coordinator of this site? Confirm its status | Kaunas | Lithuania | Not yet recruiting |
| University of Groningen and University Medical Centre Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
| University Medical Centre Rotterdam - Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Not yet recruiting |
| Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT) Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
| Karolinska Institutet (Stockholm) Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Not yet recruiting |
| Rutgers New Jersey Medical School (New York) Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.