NCT06717919Recrutement en cours
HOPE Against Cancer Recurrence in HCC
Résumé
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.
Critères d'inclusion
• 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
Critères d'exclusion
• 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
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 4
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France, Allemagne, Italie, Autriche, États-Unis, Belgique, Tchéquie, Danemark, Lituanie, Pays-Bas, Norvège, Pologne, Portugal, Espagne, Suède, Royaume-Uni
- Promoteur
- Philipp Dutkowski(Autre)
- N° de protocole
- 221622
- Pathologies
- Liver Transplantation, HCC, Oncological Outcomes
- Interventions
- Procédure
Traitements évalués
- Hypothermic oxygenated perfusion
- Conventional cold storage
Lieux · 10
- Geneva, SuisseHôpitaux universitaires de GenèveRecrute dans ce centre
- Udine, ItalieUniversity of UdineRecrute dans ce centre
- Innsbruck, AutricheMedical University of InnsbruckRecrute dans ce centre
- Vienna, AutricheMedical University of ViennaRecrute dans ce centre
- Leuven, BelgiqueUniversity Hospitals LeuvenRecrute dans ce centre
- Woluwe-Saint-Lambert, BelgiqueInstitut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)Recrute dans ce centre
- Prague, TchéquieInstitute for Clinical and Experimental Medicine (IKEM) (Prague)Recrute dans ce centre
- Copenhagen, DanemarkCopenhagen University HospitalRecrute dans ce centre
- Gdansk, PologneDepartment of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of GdańskRecrute dans ce centre
- Stockholm, SuèdeKarolinska Institutet (Stockholm)Recrute dans ce centre
Au total, dans le monde, 10 des 37 centres listés au registre recrutent ; les 27 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 16 décembre 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.