HIPAA Compliant
ISO 27001 CertifiedActively 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 recipients 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
P
Philipp Dutkowski, Professor
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Philipp Dutkowski
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | HOPE (machine perfusion after cold storage) | Conventional cold storage (standard care) |
|---|---|---|
| What it is | Pressure-controlled, hypothermic oxygenated perfusion of donor livers using devices such as VitaSmart, Liver Assist, or Perlife, performed after initial cold storage and before transplantation. | Static cold storage of donor livers in precooled preservation solution (e.g., IGL-1, HTK, UW, or Celsior) at approximately 4°C, in line with national or local standards. |
| Role in the trial | Investigational arm testing whether HOPE reduces HCC recurrence and improves post-transplant outcomes versus standard storage in adults undergoing liver transplantation. | Active comparator arm representing current established standard-of-care storage approach for donor livers in this population. |
| Primary use | To assess whether machine perfusion with oxygenated, cooled solution before transplant may lower hepatocellular carcinoma (HCC) recurrence and improve post-transplant outcomes. | Conventional method for preserving donor livers prior to transplantation, aiming to minimize ischemic injury until transplantation. |
| How it is given or performed | Donor livers are initially cold-stored, then connected to a machine for 2+ hours of hypothermic, oxygenated perfusion at the recipient center using specialized perfusion solutions, performed after bench preparation and before transplantation. | Donor livers are stored statically in cold preservation solution (4°C) using recognized solutions and methods until transplantation, in accordance with each center’s standard practice. |
| Evidence status | The HOPE4Cancer trial is recruiting and will provide prospective evidence on the effectiveness of machine perfusion with oxygenated solution in reducing HCC recurrence after liver transplantation. | Cold storage is the widely established organ preservation method with extensive clinical evidence supporting its role in successful liver transplantation. |
| Important limitations | Clinical benefits and long-term safety of HOPE for lowering HCC recurrence after transplant are not yet established; may require specialized devices and trained personnel. | Cold storage can result in ischemia-reperfusion injury, which may contribute to post-transplant complications; does not offer metabolic or oxygen support to the organ during storage. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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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
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/Philipp Dutkowski
Lead Sponsor
