NCT06717919Recruiting
HOPE Against Cancer Recurrence in HCC
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.
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)
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Belgium, Czechia, Denmark, Lithuania, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom
- Sponsor
- Philipp Dutkowski(Other)
- Protocol no.
- 221622
- Conditions
- Liver Transplantation, HCC, Oncological Outcomes
- Interventions
- Procedure
Treatments studied
- Hypothermic oxygenated perfusion
- Conventional cold storage
Locations · 10
- Geneva, SwitzerlandHôpitaux universitaires de GenèveRecruiting at this site
- Udine, ItalyUniversity of UdineRecruiting at this site
- Innsbruck, AustriaMedical University of InnsbruckRecruiting at this site
- Vienna, AustriaMedical University of ViennaRecruiting at this site
- Leuven, BelgiumUniversity Hospitals LeuvenRecruiting at this site
- Woluwe-Saint-Lambert, BelgiumInstitut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)Recruiting at this site
- Prague, CzechiaInstitute for Clinical and Experimental Medicine (IKEM) (Prague)Recruiting at this site
- Copenhagen, DenmarkCopenhagen University HospitalRecruiting at this site
- Gdansk, PolandDepartment of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of GdańskRecruiting at this site
- Stockholm, SwedenKarolinska Institutet (Stockholm)Recruiting at this site
In total, worldwide, 10 of the 37 sites listed in the registry are recruiting; the other 27 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: December 16, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.