RecruitingPHASE4INTERVENTIONAL

HOPE Against Cancer Recurrence in HCC

This study, called HOPE Against Cancer Recurrence in HCC, is investigating a new technique for preparing donor livers before a transplant. For patients with a type of liver cancer called hepatocellular carcinoma (HCC), a liver transplant can be life-saving. However, sometimes the cancer can return. This research compares two ways of storing donor livers: the usual method of just keeping them cold, and a new method called hypothermic oxygenated perfusion (HOPE). HOPE involves gently flushing the liver with a special oxygen-rich fluid while it's cold, which researchers believe might improve the liver's quality and reduce the chance of cancer coming back after the transplant. The study aims to see if patients who receive livers prepared with HOPE have a longer period without their cancer returning.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Philipp Dutkowski

Enrolment target

220

Start

01 Aug 2025

Estimated completion

31 Jan 2028

Liver Transplantation HCC Oncological Outcomes

What is this study about?

For people living with a type of liver cancer called hepatocellular carcinoma (HCC), especially if their liver isn't working properly due to other conditions like cirrhosis, a liver transplant can be the best path to a healthier life. However, even after a successful transplant, the cancer can sometimes come back. This happens in about 15 out of every 100 patients, and the quality of the donated liver might play a role in this.

That's where this study comes in. It's looking at a new technique called 'machine liver perfusion,' specifically 'hypothermic oxygenated perfusion' (HOPE). Imagine a process where, before the liver is transplanted into a patient, it's gently flushed with a special fluid that's rich in oxygen and kept at a cool temperature. This is thought to help improve the liver's health and condition before it's placed into a new body. The usual way of preparing a liver for transplant is simply to keep it cold without this extra flushing.

The main goal of this study is to compare how well patients do after a liver transplant for HCC, depending on whether their donor liver was prepared using this new HOPE method or the standard cooling method. Researchers want to see if patients who receive a HOPE-prepared liver have a better chance of staying cancer-free for longer after their transplant. This research is happening in transplant centres around the world and involves around 220 adult patients with HCC who are waiting for a liver transplant.

Key takeaways

This study compares two ways of preparing donor livers for transplant.
It aims to see if a new method (HOPE) can reduce liver cancer recurrence.
Participation involves being randomly assigned to a treatment group.
You'll be carefully monitored for at least two years after your transplant.
The study focuses on adult patients with HCC needing a liver transplant.

Who may be eligible?

To be part of this study, you need to be an adult (over 18 years old) who is on the waiting list for a liver transplant because of hepatocellular carcinoma (HCC). Your HCC diagnosis must be confirmed by scans or a biopsy, and it generally needs to fit within certain size and number limits for the tumours. Even if your cancer was initially larger, you might still be eligible if treatments have successfully reduced its size.

There are also some reasons why you wouldn't be able to join. For example, if the donated liver is from someone who had a specific type of death (called 'donation after circulatory death') or if you're having only part of a liver transplanted. You also wouldn't be able to participate if your liver cancer is a mixed type, or if you're currently receiving certain types of anti-cancer medications, or if you're pregnant.

Finally, the study needs your full understanding and written agreement to take part. Also, for both groups in the study, the donor liver must not have been stored for longer than 10 hours before transplantation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Are you on the waiting list for a liver transplant due to HCC?
Has your HCC been confirmed by scans or a biopsy?
Are you able to provide written consent to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first give your informed consent, meaning you understand the study and agree to participate. You would then be randomly assigned to one of two groups: either your donor liver would be prepared using the new method (HOPE) or the standard cooling method. You wouldn't get to choose which group you're in, as this helps make the study fair and scientific.

After your liver transplant, doctors would follow your health very closely for at least two years. This involves regular check-ups, scans, and tests, similar to what you'd have after any liver transplant, but with specific attention to whether the cancer returns. The medical team will be tracking your progress and survival without cancer recurring. There are no additional medications specifically for the study that you would take, as the study focuses on how the donor liver is prepared. The total duration of your active participation, including follow-up, would be for at least two years after your transplant.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a liver that has been prepared using a technique designed to improve its quality, which could potentially lower your chance of cancer recurrence after transplant. However, because this is a study, we don't yet know for sure if the new method is better than the standard. There are no known additional risks to you from the HOPE procedure itself beyond the usual risks associated with a liver transplant and the standard organ preservation method. You would receive excellent medical care regardless of which group you are in. It's important to remember that participating in any clinical study is always voluntary, and you have the right to withdraw at any time without affecting your medical care.

Locations (37)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Rutgers New Jersey Medical School (New York)
Verified postcode
New York, United States· Not yet recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Not yet recruiting
Medical University of Innsbruck
Verified postcode
Innsbruck, Austria· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
University Hospitals Leuven
Verified postcode
Leuven, Belgium· Recruiting
Institut de Recherche Expérimentale et Clinique (IREC) UCLouvain (Brussels)
Verified postcode
Woluwe-Saint-Lambert, Belgium· Recruiting
Institute for Clinical and Experimental Medicine (IKEM) (Prague)
Verified postcode
Prague, Czechia· Recruiting
Copenhagen University Hospital
Verified postcode
Copenhagen, Denmark· Recruiting
Hôpital de la Croix-Rousse (Lyon)
Verified postcode
Lyon, France· Not yet recruiting
Universitätsklinikum Essen
Verified postcode
Essen, Germany· Not yet recruiting
University Medical Centre Hamburg-Eppendorf
Unverified
Hamburg-Eppendorf, Germany· Not yet recruiting
Hannover Medical School
Verified postcode
Hanover, Germany· Not yet recruiting

Common questions

What is HCC?

HCC stands for Hepatocellular Carcinoma, which is the most common type of liver cancer, often linked to conditions like cirrhosis.

What is a liver transplant?

A liver transplant is a major operation where a diseased or damaged liver is removed and replaced with a healthy liver from a donor.

What is 'random allocation'?

Random allocation means being assigned by chance to one of the study groups, like flipping a coin. This ensures the study is as fair as possible.

Will I know if my liver was treated with HOPE?

Because this is a study, you might not know which method was used to prepare your specific donor liver until after the study has concluded and results are analysed. This is to prevent bias.

How long will I be followed in the study?

You will be followed by the study team for at least two years after your liver transplant to monitor your health and check for cancer recurrence.

How to find out more

Philipp Dutkowski, Professor

philipp.dutkowski@clarunis.ch 0041 61 777 73 06 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.