Actively Recruiting
Led by Philipp Dutkowski · Updated on 2025-12-16
220
Participants Needed
37
Research Sites
N/A
Total Duration
Researchers are investigating liver transplantation for hepatocellular carcinoma (HCC) in adults with impaired liver function due to cirrhosis. The study compares survival after tumor recurrence between patients receiving livers preserved with hypothermic oxygenated perfusion (HOPE) and those receiving livers stored by the standard cold storage method. The trial aims to determine if perfusing the liver before transplantation improves outcomes by reducing tumor recurrence. Participants will be randomly assigned to one of two groups: the experimental group where livers undergo machine perfusion using devices like VitaSmart, Liver Assist, or Perlife with oxygenated fluid at cold temperatures before transplant, or the control group where livers are preserved by conventional cold storage according to local standards. Perfusion is performed in the recipient center for at least 2 hours, continuing until the recipient's hepatectomy is complete. The study includes transplant centers worldwide and targets 220 patients. Participants will be followed for at least 2 years after transplantation. Researchers will assess recurrence-free survival at 24 months and monitor tumor recurrence, liver-related complications, rejection activity, and levels of tumor DNA and proteins in blood at set intervals. The trial uses randomization and double-blinding to compare outcomes between groups and aims to provide insights into improving liver transplant success in HCC patients.
CONDITIONS
HOPE Against Cancer Recurrence in HCC
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Day of transplant
Participants receive liver transplantation using either conventional cold storage or hypothermic oxygenated perfusion of the liver graft before implantation.
1 transplant procedure visit (in-person)
Duration - Up to 24 months
Participants are monitored for cancer recurrence, liver complications, and survival outcomes after transplantation.
Regular follow-up visits up to 24 months
Total: 37 locations
1
Rutgers New Jersey Medical School (New York)
New York, New York, United States, 07103
Not Yet Recruiting
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
3
Medical University of Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
4
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
5
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
6
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
Woluwe-Saint-Lambert, Belgium, 1200
Actively Recruiting
7
Institute for Clinical and Experimental Medicine (IKEM) (Prague)
Prague, Czechia, 14021
Actively Recruiting
8
Copenhagen University Hospital
Copenhagen, Denmark, 2100
Actively Recruiting
9
Hôpital de la Croix-Rousse (Lyon)
Lyon, France, 69004
Not Yet Recruiting
10
Universitätsklinikum Essen
Essen, Germany, 45122
Not Yet Recruiting
11
University Medical Centre Hamburg-Eppendorf
Hamburg-Eppendorf, Germany, 20246
Not Yet Recruiting
12
Hannover Medical School
Hanover, Germany, 30626
Not Yet Recruiting
13
University of Heidelberg
Heidelberg, Germany, 69120
Not Yet Recruiting
14
University of Mainz
Mainz, Germany, 55131
Not Yet Recruiting
15
University of Munich Grosshadern
München, Germany, 81377
Not Yet Recruiting
16
Milano Institutio Nazionale dei Tumori (Milan)
Milan, Italy, 20133
Not Yet Recruiting
17
ASST Grande Ospedale Metropolitano Niguarda (Milan)
Milan, Italy, 20162
Not Yet Recruiting
18
Padova University Hospital
Padova, Italy, 35128
Not Yet Recruiting
19
Gemelli University Hospital
Rome, Italy, 00168
Not Yet Recruiting
20
University of Udine
Udine, Italy, 33100
Actively Recruiting
21
Lithuanian University of Health Sciences
Kaunas, Lithuania, 50009
Not Yet Recruiting
22
University of Groningen and University Medical Centre Groningen
Groningen, Netherlands, 9713
Not Yet Recruiting
23
University Medical Centre Rotterdam - Erasmus University Medical Center
Rotterdam, Netherlands, 3015
Not Yet Recruiting
24
Oslo University Hospital
Oslo, Norway, 0450
Not Yet Recruiting
25
Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk
Gdansk, Poland, 80-210
Actively Recruiting
26
Medical University of Warsaw
Warsaw, Poland, 02-097
Not Yet Recruiting
27
Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)
Lisbon, Portugal, 1069-166
Not Yet Recruiting
28
Vall d'Hebron Barcelona Hospital Campus
Barcelona, Spain, 08035
Not Yet Recruiting
29
Karolinska Institutet (Stockholm)
Stockholm, Sweden, 17177
Actively Recruiting
30
Clarunis - University Digestive Health Care
Basel, Canton of Basel-City, Switzerland, 4031
Not Yet Recruiting
31
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Not Yet Recruiting
32
Hôpitaux universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
33
University Hospitals Birmingham
Birmingham, United Kingdom, B15 2GW
Not Yet Recruiting
34
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS97TF
Not Yet Recruiting
35
The Royal Free Hospital (London)
London, United Kingdom, NW3 2QG
Not Yet Recruiting
36
King's College Hospital (London)
London, United Kingdom, SE5 9RS
Not Yet Recruiting
37
Freeman Hospital (Newcastle)
Newcastle, United Kingdom, NE7 7DN
Not Yet Recruiting
P
Philipp Dutkowski, Professor
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Janina Eden, Philip C Müller, Christoph Kuemmerli...
https://pubmed.ncbi.nlm.nih.gov/41013675