NCT06717919 HOPE Against Cancer Recurrence in HCC
| NCT ID | NCT06717919 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Philipp Dutkowski |
| Condition | Liver Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 220 participants in total. It began in 2025-08-01 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06717919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06717919 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06717919 currently recruiting?
Yes, NCT06717919 is actively recruiting participants. Contact the research team at philipp.dutkowski@clarunis.ch for enrollment information.
Where is the NCT06717919 trial being conducted?
This trial is being conducted at New York, United States, Cleveland, United States, Innsbruck, Austria, Vienna, Austria and 11 additional locations.
Who is sponsoring the NCT06717919 clinical trial?
NCT06717919 is sponsored by Philipp Dutkowski. The trial plans to enroll 220 participants.