HOPE Against Cancer Recurrence in HCC
HOPE4Cancer
Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
1 other identifier
interventional
220
17 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2025
Typical duration for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2024
CompletedFirst Posted
Study publicly available on registry
December 5, 2024
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
December 16, 2025
December 1, 2025
2.5 years
November 27, 2024
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence free survival
Post transplant HCC recurrence free survival, i.e. the time interval a patient is alive without HCC recurrence after transplantation, i.e., until either HCC recurrence is observed, or the patient dies from any cause.
24 months
Secondary Outcomes (10)
HCC recurrence (while alive)
24 months
HCC recurrence (while alive)
24 months
HCC-related death
24 months
HCC-related death
24 months
Death from any other causes than HCC
24 months
- +5 more secondary outcomes
Study Arms (2)
Conventional cold storage
ACTIVE COMPARATORConventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.
Hypothermic oxygenated perfusion
EXPERIMENTALAll study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation. The perfusion devices are routinely used in all participating centres (VitaSmart, Bridge to Life®, Liver Assist, XVIVO®, Perlife, Aferitica®).
Interventions
All study centres will use either VitaSmart, Liver assist or Perlife devices for machine liver perfusion, with a pressure controlled hypothermic oxygenated liver perfusion through the portal vein (HOPE) or through the portal vein and the hepatic artery (DHOPE), targeting a flow rate between 200-250 ml/min at a pressure of 3 mmHg, and a perfusate temperature between 8-12°C. The perfusate consists of 3L re-circulating Belzer MPS® (Bridge to Life Ltd.) with an active oxygenation (70-110 kPa). The minimum perfusion duration is defined at 2 hours, while perfusion is generally continued until the recipient hepatectomy is completed. The perfusion will exclusively be performed in the recipient centre after initial cold storage and bench preparation of the liver for implantation. The perfusion devices are routinely used in all participating centres.
Conventional cold storage at 4°C will be performed with precooled preservation solution according to local standard of care. For cold storage at the Swiss centres, IGL-1 (Institute George Lopez) is used for cold storage. Liver transplant centres in other European countries, use mainly three other storage solutions (Histidine trypophan-ketoglutarat, HTK and University of Wisconsin, UW solution, Celsior) in accordance to their national guidelines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Rutgers New Jersey Medical School (New York)
New York, New York, 07103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Medical University of Innsbruck
Innsbruck, 6020, Austria
Medical University of Vienna
Vienna, 1090, Austria
University Hospitals Leuven
Leuven, 3000, Belgium
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
Woluwe-Saint-Lambert, 1200, Belgium
Institute for Clinical and Experimental Medicine (IKEM) (Prague)
Prague, 14021, Czechia
Copenhagen University Hospital
Copenhagen, 2100, Denmark
Hôpital de la Croix-Rousse (Lyon)
Lyon, 69004, France
Universitätsklinikum Essen
Essen, 45122, Germany
University Medical Centre Hamburg-Eppendorf
Hamburg-Eppendorf, 20246, Germany
Hannover Medical School
Hanover, 30626, Germany
University of Heidelberg
Heidelberg, 69120, Germany
University of Mainz
Mainz, 55131, Germany
University of Munich Grosshadern
München, 81377, Germany
Milano Institutio Nazionale dei Tumori (Milan)
Milan, 20133, Italy
ASST Grande Ospedale Metropolitano Niguarda (Milan)
Milan, 20162, Italy
Padova University Hospital
Padua, 35128, Italy
Gemelli University Hospital
Rome, 00168, Italy
University of Udine
Udine, 33100, Italy
Lithuanian University of Health Sciences
Kaunas, 50009, Lithuania
University of Groningen and University Medical Centre Groningen
Groningen, 9713, Netherlands
University Medical Centre Rotterdam - Erasmus University Medical Center
Rotterdam, 3015, Netherlands
Oslo University Hospital
Oslo, 0450, Norway
Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk
Gdansk, 80-210, Poland
Medical University of Warsaw
Warsaw, 02-097, Poland
Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)
Lisbon, 1069-166, Portugal
Vall d'Hebron Barcelona Hospital Campus
Barcelona, 08035, Spain
Karolinska Institutet (Stockholm)
Stockholm, 17177, Sweden
Clarunis - University Digestive Health Care
Basel, Canton of Basel-City, 4031, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Hôpitaux universitaires de Genève
Geneva, 1205, Switzerland
University Hospitals Birmingham
Birmingham, B15 2GW, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS97TF, United Kingdom
The Royal Free Hospital (London)
London, NW3 2QG, United Kingdom
King's College Hospital (London)
London, SE5 9RS, United Kingdom
Freeman Hospital (Newcastle)
Newcastle, NE7 7DN, United Kingdom
Related Publications (1)
Eden J, Muller PC, Kuemmerli C, Peters F, Litke T, Kranich A, Kremer AE, von Felten S, Dutkowski P; HOPE4Cancer Trial Investigators. Hypothermic oxygenated perfusion (HOPE) against cancer recurrence after liver transplantation for hepatocellular carcinoma-study protocol for an international multicenter randomized controlled trial (HOPE4Cancer). Trials. 2025 Sep 26;26(1):369. doi: 10.1186/s13063-025-09120-1.
PMID: 41013675DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor representative and Principal Investigator
Study Record Dates
First Submitted
November 27, 2024
First Posted
December 5, 2024
Study Start
August 1, 2025
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share