HOPE Against Cancer Recurrence in HCC (NCT06717919)
Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Rutgers New Jersey Medical School (New York) — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
- Hypothermic oxygenated perfusion (PROCEDURE)
- Conventional cold storage (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Rutgers New Jersey Medical School (New York) — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Medical University of Innsbruck — Innsbruck,
- Medical University of Vienna — Vienna,
- University Hospitals Leuven — Leuven,
- Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels) — Woluwe-Saint-Lambert,
- Institute for Clinical and Experimental Medicine (IKEM) (Prague) — Prague,
- Copenhagen University Hospital — Copenhagen,
- Hôpital de la Croix-Rousse (Lyon) — Lyon,
- Universitätsklinikum Essen — Essen,
- University Medical Centre Hamburg-Eppendorf — Hamburg-Eppendorf,
- Hannover Medical School — Hanover,
- University of Heidelberg — Heidelberg,
- University of Mainz — Mainz,
- University of Munich Grosshadern — München,
- Milano Institutio Nazionale dei Tumori (Milan) — Milan,
- ASST Grande Ospedale Metropolitano Niguarda (Milan) — Milan,
- Padova University Hospital — Padova,
- Gemelli University Hospital — Rome,
- University of Udine — Udine,
- Lithuanian University of Health Sciences — Kaunas,
- University of Groningen and University Medical Centre Groningen — Groningen,
- University Medical Centre Rotterdam - Erasmus University Medical Center — Rotterdam,
- Oslo University Hospital — Oslo,
- Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk — Gdansk,
📞 Contact the Study Coordinator
Phone: 0041 61 777 73 06
Email: philipp.dutkowski@clarunis.ch
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation — Cleveland, Ohio
- Restrictive Fluid Management In Liver Transplantation (REFIL) - Pilot — Vancouver, British Columbia
- Continued Access Study to Evaluate Performance of the Organ Recovery Systems _LifePort® Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT™_CA) — Chicago, Illinois
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.