Liver TransplantationPhase 4HOPE4CancerNCT06717919

HOPE Against Cancer Recurrence in HCC

A Phase 4 study testing Hypothermic oxygenated perfusion and Conventional cold storage in people with Liver Transplantation and HCC, run by Philipp Dutkowski at 37 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Transplantation, HCC, Oncological Outcomes
What is being tested?: Hypothermic oxygenated perfusion and Conventional cold storage
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 37 sitesin 17 countries
Study dates: 1 Aug 2025to 31 Jan 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

Acute and unexpected medical contraindications
Pregnancy
Cold storage time of > 10 hours (both study arms)

Trial locations and contacts

37 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Philipp Dutkowski, Professor contact

0041 61 777 73 06

philipp.dutkowski@clarunis.ch

Country

City, postcode or hospital

Sites recruiting now only

37 sites in 17 countries

Germany6 sites, 6 recruiting

Universitätsklinikum Essen
Essen, 45122
Ulf Neumann, Prof, 0049 201 / 723- 84002, Ulf.Neumann@uk-essen.de
Ulf Neumann, 020172384002, Ulf.Neumann@uk-essen.de
Not yet recruiting
University Medical Centre Hamburg-Eppendorf
Hamburg-Eppendorf, 20246
Uta Herden, Prof. Dr., +49 40 7410-56640, j.jahnke-triankowski@uke.de
Uta Herden, Prof. Dr.
Not yet recruiting
Hannover Medical School
Hanover, 30626
Cornelius van Beekum, Dr., +49511-532 6534/6527, vanBeekum.Cornelius@mh-hannover.de
Cornelius van Beekum, Dr
Not yet recruiting
University of Heidelberg
Heidelberg, 69120
Deniz Uluk, Dr, +49 6221 5634357, Deniz.Uluk@med.uni-heidelberg.de
Deniz Uluk, Dr
Not yet recruiting
University of Mainz
Mainz, 55131
Jens Mitler, Dr., 0049 160 96952448, Jens.Mittler@unimedizin-mainz.de
Jens Mitler, Dr
Not yet recruiting
University of Munich Grosshadern
München, 81377
Dionysios Koliogiannis, Dr., +49 89 4400-76573, Dionysios.Koliogiannis@med.uni-muenchen.de
Dionysios Koliogiannis
Not yet recruiting

Other trials in Germany

Italy5 sites, 5 recruiting

Milano Institutio Nazionale dei Tumori (Milan)
Milan, 20133
Vincenzo Mazzaferro, Prof, +39 02 23902338, vincenzo.mazzaferro@istitutotumori.mi.it
Vincenzo Mazzaferro, 0223902338, vincenzo.mazzaferro@istitutotumori.mi.it
Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda (Milan)
Milan, 20162
Riccardo de Carlis, Dr., +39 02 64444617, riccardo.decarlis@ospedaleniguarda.it
Riccardo de Carlis, Dr.
Not yet recruiting
Padova University Hospital
Padova, 35128
Umberto Cillo, Prof, +39 0496366593, cillo@unipd.it
Umberto Cillo, Prof.
Not yet recruiting
Gemelli University Hospital
Rome, 00168
Marco Maria Pascale, Prof, +39 630156578, marcomaria.pascale@policlinicogemelli.it
Marco Maria Pascale, Prof
Not yet recruiting
University of Udine
Udine, 33100
Umberto Baccarani, Prof, +39 0432 5521, umberto.baccarani@uniud.it
Umberto Baccarani, Prof
Recruiting

Other trials in Italy

United Kingdom5 sites, 5 recruiting

University Hospitals Birmingham
Birmingham, B15 2GW
Rebeca Sanabria Mateos, Dr., +44121 371 2000, rebeca.sanabriamateos@uhb.nhs.uk
Rebeca Sanabria Mateos, Dr
Not yet recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS97TF
Barbara Fiore, Dr., +441132068378, barbara.fiore@nhs.net
Barbara Fiore, Dr
Not yet recruiting
The Royal Free Hospital (London)
London, NW3 2QG
Joerg-Matthias Pollok, Prof, +4420 7794 0500, joerg-matthias.pollok@nhs.net
Joerg-Matthias Pollok, Prof
Not yet recruiting
King's College Hospital (London)
London, SE5 9RS
Miriam Cortes Cerisuelo, Dr., +4420 3299 6337, m.cortescerisuelo@nhs.net
Miriam Cortes Cerisuelo, Dr
Not yet recruiting
Freeman Hospital (Newcastle)
Newcastle, NE7 7DN
Rodrigo Figueiredo, +44191 213 7144, r.figueiredo@nhs.net
Rodrigo Figueiredo
Not yet recruiting

Other trials in United Kingdom

Switzerland3 sites, 3 recruiting

Clarunis - University Digestive Health Care
Basel, Canton of Basel-City, 4031
Philipp Dutkowski, Prof. Dr., +41 61 77 314, philipp.dutkowski@usb.ch
Philipp Dutkowski, Prof. Dr.
Not yet recruiting
Hôpitaux universitaires de Genève
Geneva, 1205
Philippe Compagnon, Prof. Dr., 079 553 08 02, philippe.compagnon@hcuge.ch
Philippe Compagnon, Prof. Dr.
Recruiting
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Andreas Kremer, Prof. Dr., +41 44 255 85 48, andreas.kremer@usz.ch
Andreas Kremer, Prof. Dr.
Not yet recruiting

Other trials in Switzerland

United States2 sites, 2 recruiting

Cleveland Clinic
Cleveland, Ohio, 44195
Andrea Schlegel, Prof., +1216.444.2200, Schlegel.Andrea@outlook.de
Andrea Schlegel, Prof
Not yet recruiting
Rutgers New Jersey Medical School (New York)
New York, New York, 07103
James Guarerra, Prof, +19739729412, james.guarrera@njms.rutgers.edu
James Guarerra, Prof
Not yet recruiting

Other trials in United States

Austria2 sites, 2 recruiting

Medical University of Innsbruck
Innsbruck, 6020
Stefan Schneeberger, Prof.Dr., +43(0)512 504 22600, stefan.schneeberger@i-med.ac.at
Stefan Schneeberger, Prof. Dr.
Recruiting
Medical University of Vienna
Vienna, 1090
Thomas Soliman, +43 140 400 687 30, thomas.soliman@meduniwien.ac.at
+43 140 400 687 30
Recruiting

Other trials in Austria

Belgium2 sites, 2 recruiting

University Hospitals Leuven
Leuven, 3000
Diethard Monbaliu, Prof. Dr., +32 16 34 12 17, diethard.monbaliu@uzleuven.be
Diethard Monbaliu, Dr.
Recruiting
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
Woluwe-Saint-Lambert, 1200
Eliano Bonaccorsi Riani, Dr., +32 2 764 19 92, eliano.bonaccorsi@saintluc.uclouvain.be
Eliano Bonaccorsi Riani, Dr.
Recruiting

Other trials in Belgium

Netherlands2 sites, 2 recruiting

University of Groningen and University Medical Centre Groningen
Groningen, 9713
Vincent De Meijer, Prof. Dr., +31 50 361 2896, v.e.de.meijer@umcg.nl
Vincent De Meijer, Prof. Dr
Not yet recruiting
University Medical Centre Rotterdam - Erasmus University Medical Center
Rotterdam, 3015
Jeroen De Jonge, Dr., +31 107 031 810, j.dejonge.1@erasmusmc.nl
Jeroen De Jonge, Dr.
Not yet recruiting

Other trials in Netherlands

Poland2 sites, 2 recruiting

Department of Surgical Oncology, Transplant Surgery and General Surgery, Medical University of Gdańsk
Gdansk, 80-210
Piotr Domagola, Prof., +48 58 584 67 33, domagala.piotr@gumed.edu.pl
Piotr Domagola, Prof
Recruiting
Medical University of Warsaw
Warsaw, 02-097
Michal Grat, Prof, +48225992545, michal.grat@wum.edu.pl
Michal Grat, Prof
Not yet recruiting

Other trials in Poland

Czechia1 site, 1 recruiting

Institute for Clinical and Experimental Medicine (IKEM) (Prague)
Prague, 14021
Jiri Fronek, Prof., +42023 605 5185, jiri.fronek@ikem.cz
Jiri Fronek, Prof
Recruiting

Other trials in Czechia

Denmark1 site, 1 recruiting

Copenhagen University Hospital
Copenhagen, 2100
Hans Christian Pommergaard, Prof. Dr., +45 23 24 18 21, hans-christian.pommergaard@regionh.dk
Hans Christian Pommergaard, Prof. Dr.
Recruiting

Other trials in Denmark

France1 site, 1 recruiting

Hôpital de la Croix-Rousse (Lyon)
Lyon, 69004
Xavier Müller, Prof, +33472118088, xavier.muller@chu-lyon.fr
Xavier Müller, Prof
Not yet recruiting

Other trials in France

Lithuania1 site, 1 recruiting

Lithuanian University of Health Sciences
Kaunas, 50009
Povilas Ignatavičius, Ass-Prof, +370 37 326857, povilas.ignatavicius@lsmu.lt
Povilas Ignatavičius, Ass-Prof
Not yet recruiting

Other trials in Lithuania

Norway1 site, 1 recruiting

Oslo University Hospital
Oslo, 0450
Morten Hagness, Dr, +47 23 07 12 36, mhagness@ous-hf.no
Morten Hagness, Dr
Not yet recruiting

Other trials in Norway

Portugal1 site, 1 recruiting

Centro Hepato-Bilio-Pancreático e de Transplantação (CHBPT)
Lisbon, 1069-166
Hugo Pinto Marques, Prof
Hugo Pinto Marques
Not yet recruiting

Other trials in Portugal

Spain1 site, 1 recruiting

Vall d'Hebron Barcelona Hospital Campus
Barcelona, 08035
Mireira Caralt Barba, Prof, mireia.caralt@vallhebron.cat
Mireira Caralt Barba, Prof
Not yet recruiting

Other trials in Spain

Sweden1 site, 1 recruiting

Karolinska Institutet (Stockholm)
Stockholm, 17177
Gabriel Oniscu, Prof, +46 8-123 825 64, gabriel.oniscu@ki.se
Gabriel Oniscu, Prof
Recruiting

Other trials in Sweden

About this study

Official title: Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT

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.

Conditions: Liver Transplantation, HCC, Oncological Outcomes
Being tested: Hypothermic oxygenated perfusion, Conventional cold storage
Keywords: HOPE, randomised controlled trial, multicentre, hepatocellular carcinoma, liver transplantation
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypothermic oxygenated perfusionProcedure or surgery
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 storageProcedure or surgery
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.

Study groups in NCT06717919
Study group	Role	What they receive
Conventional cold storage	Active comparator	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. Receives: Procedure: Conventional cold storage
Hypothermic oxygenated perfusion	Experimental	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 (VitaSmart, Bridge to Life®, Liver Assist, XVIVO®, Perlife, Aferitica®). Receives: Procedure: Hypothermic oxygenated perfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 months

Secondary outcomes (10)

HCC recurrence (while alive)
Number of HCC recurrences
Measured: 24 months
HCC recurrence (while alive)
Time to recurrence of HCC
Measured: 24 months
HCC-related death
Death related to HCC
Measured: 24 months
HCC-related death
Time to HCC related death
Measured: 24 months
Death from any other causes than HCC
Death not related to HCC
Measured: 24 months
Death from any other causes than HCC
Time to death not related to HCC
Measured: 24 months
Mean number of circulating tumour deoxyribonucleic acid (DNA) in blood
This will be measured before transplantation (baseline), at discharge and at 6 months after transplantation. This endpoint will add information on the risk of tumour recurrence by seeding circulating cells.
Measured: 6 months
Mean number of high-mobility-group-protein B1 (HMGB-1) in blood
This will be measured at the time of transplantation (baseline) and 1 week after transplantation.
This endpoint will add information on danger signalling in both study arms during early and late reperfusion.
Measured: 1 week
Median Rejection Activity Index
The Rejection Activity Index (RAI) in liver histology (biopsy) is performed at 6 months after transplantation. This endpoint assessed in liver histology (biopsy) will show endothelial and T cell activation in implanted livers within the first months after 6 months.
The RAI can be used to score liver allograft biopsies with acute rejection. The scale is from 1 to 9, higher scores mean more severe signs of rejection.
Measured: 6 months
Liver related complications
This endpoint will allow to assess the association between initial graft injury and liver specific complications in both study arms.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202531 Jan 2028

First posted5 Dec 2024
Study start1 Aug 2025
Primary completion31 Jan 2028 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver TransplantationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06717919
Sponsor's protocol ID: 221622
Acronym: HOPE4Cancer
Status last verified: Dec 2025
First submitted: 27 Nov 2024
Last updated: 16 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41013675

Interested in taking part?

Philipp Dutkowski, Professor

0041 61 777 73 06

philipp.dutkowski@clarunis.ch

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease

All Liver Transplantation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypothermic Oxygenated Perfusion (HOPE) Against Cancer Recurrence in HCC Liver Transplantation - International Multicentre Parallel Group Interventional RCT
ClinicalTrials.gov ID: NCT06717919
Acronym / sponsor ID: HOPE4Cancer / 221622
Conditions: Liver Transplantation, HCC, Oncological Outcomes
Keywords: HOPE, randomised controlled trial, multicentre, hepatocellular carcinoma, liver transplantation
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 220 participants (estimated)
Lead sponsor: Philipp DutkowskiUniversity, hospital or other
Study start: 1 Aug 2025 (actual)
Primary completion: 31 Jan 2028 (estimated)
Study completion: 31 Jan 2028 (estimated)
First posted: 5 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Conventional cold storage	Active comparator	Procedure: Conventional cold storageConventional 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	Experimental	Procedure: Hypothermic oxygenated perfusionAll 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®).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypothermic oxygenated perfusionAll 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.	Procedure or surgery	Hypothermic oxygenated perfusion
Conventional cold storageConventional 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.	Procedure or surgery	Conventional cold storage

Primary outcome

Recurrence free survival
Time frame: 24 months
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.

10 secondary outcomes

HCC recurrence (while alive)
Time frame: 24 months
HCC recurrence (while alive)
Time frame: 24 months
HCC-related death
Time frame: 24 months
HCC-related death
Time frame: 24 months
Death from any other causes than HCC
Time frame: 24 months
Death from any other causes than HCC
Time frame: 24 months
Mean number of circulating tumour deoxyribonucleic acid (DNA) in blood
Time frame: 6 months
Mean number of high-mobility-group-protein B1 (HMGB-1) in blood
Time frame: 1 week
Median Rejection Activity Index
Time frame: 6 months
Liver related complications
Time frame: 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Derived from this study: PubMed 41013675Eden 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.
Individual participant dataSharing planned: No

Related trials for Liver Transplantation

Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Philipp Dutkowski, Professor contact

0041 61 777 73 06

philipp.dutkowski@clarunis.ch

37 sites in 17 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hypothermic oxygenated perfusion and Conventional cold storage in people with Liver Transplantation and HCC, run by Philipp Dutkowski at 37 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, Italy, United Kingdom, Switzerland, United States and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philipp Dutkowski, Professor (0041 61 777 73 06, philipp.dutkowski@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06717919, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.