RecruitingPHASE2INTERVENTIONAL

Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma

This UK clinical trial is testing a new treatment called Atezolizumab-Bevacizumab for people who have had a liver transplant and whose liver cancer (hepatocellular carcinoma) has returned and is advanced. Currently, treatment options often don't work very well and can have side effects. This new treatment combination has shown promising results in other patients, but its safety and effectiveness haven't been studied in liver transplant patients before. The main goal is to check how safe this combination is, especially looking at the risk of the body rejecting the transplanted liver, over the first six months. Researchers will also look at how well the treatment shrinks the cancer, how long people live without the cancer getting worse, and their overall quality of life, alongside an adjusted anti-rejection medication plan.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

22 Jan 2026

Estimated completion

01 Jan 2030

Liver Transplant Hepatocellular Carcinoma Recurrent Systemic Treatment

What is this study about?

This clinical trial is designed for people in the UK who have received a liver transplant and whose liver cancer has unfortunately come back and is now advanced. When liver cancer returns after a transplant, especially in an advanced stage, it can be very difficult to treat successfully. Current treatments, like a type of medicine called tyrosine kinase inhibitors (TKIs), often don’t work for everyone and can come with side effects that make them hard to tolerate. This means there's a real need for better and safer options for these patients.

The trial is focusing on a new treatment combination called Atezolizumab-Bevacizumab. This combination has already shown encouraging results in other studies, improving survival rates and generally being well-tolerated in patients with a similar type of cancer. However, liver transplant patients were not included in those earlier studies, so we don't yet know how safe or effective this particular combination is for them.

A key concern for liver transplant patients is the risk of their body rejecting the transplanted liver, especially when new cancer treatments are introduced. To address this, the study will use a carefully planned approach for the anti-rejection medicines (immunosuppression) that transplant patients take. The researchers hope that by adjusting these medicines, they can allow the cancer treatment to work effectively while still protecting the transplanted liver and reducing the risk of rejection. The main aim is to find out if this treatment combination is safe for liver transplant patients and also to see how well it works to control the cancer and improve life.

Key takeaways

This study is for liver transplant patients with advanced liver cancer that has returned.
It tests a new combination of medicines, Atezolizumab-Bevacizumab, to see if it's safe and works well.
A main focus is to prevent the body from rejecting the transplanted liver.
Your anti-rejection medication plan will be carefully managed as part of the study.
The study will check safety over 6 months and continue to follow participants for 24 months or more.

Who may be eligible?

This study is looking for adults aged between 18 and 90 years old who have had a liver transplant at least six months ago. The reason for waiting six months is to reduce the risk of your body rejecting the transplanted liver, which is higher in the first few months after the transplant.

You would be considered for this study if your liver cancer has returned and is advanced, meaning it cannot be treated with surgery or other local treatments. Your doctors must have discussed and recommended this specific Atezolizumab-Bevacizumab treatment for you as a first choice in a specialist meeting. Before joining, specific blood tests will be taken to ensure your liver, kidney, and blood cell counts are healthy enough for the treatment.

There are also some reasons why you might not be able to join. For example, if you have had signs of your body rejecting your transplanted liver in the three months before the study starts, or if your anti-rejection medicine review shows a high level of rejection, you would not be able to participate. You must also be able to understand and agree to follow the study's requirements.

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 between 18 and 90 years old?
Did you have your liver transplant more than 6 months ago?
Has your liver cancer come back and is it considered advanced?
Has your medical team recommended this specific treatment combination?
Are you able to attend regular hospital visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the Atezolizumab-Bevacizumab combination treatment. This will be given in hospital, likely through a drip into your arm. You will have regular hospital visits for check-ups, blood tests, scans, and to receive your medication. During these visits, the doctors will carefully monitor your health, how the treatment is affecting you, and how well your liver transplant is working, especially looking for any signs of rejection. They will also assess how the cancer is responding to treatment. You will also be on a specific, carefully adjusted anti-rejection medication plan. The total duration of your participation will depend on how the treatment progresses and your individual response, but it will involve close monitoring for at least 24 months, with safety checks specifically at 6 months.

Potential risks and benefits

Participating in this trial might offer potential benefits if the new treatment combination proves to be more effective and better tolerated than current options for advanced liver cancer after a transplant. However, as with any new treatment, there are potential risks, especially the chance of your body rejecting your transplanted liver or other side effects from the medications. The researchers will be closely monitoring you to manage any side effects. Remember, joining a trial is always voluntary, and you have the right to withdraw at any time without it affecting your future medical care.

Locations (10)

Hôpital Beaujon
Verified postcode
Clichy, France· Recruiting
Hôpital Henri-Mondor
Verified postcode
Créteil, France· Recruiting
Hôpital Claude Huriez - CHU de Lille
Verified postcode
Lille, France· Recruiting
Lyon - Hôpital Croix Rousse
Verified postcode
Lyon, France· Recruiting
CHU Montpellier - Hôpital Saint Eloi
Verified postcode
Montpellier, France· Recruiting
Hôpital Pitié-Salpêtrière
Verified postcode
Paris, France· Recruiting
CHU Rennes - Hôpital Pontchaillou
Verified postcode
Rennes, France· Recruiting
Hôpital de Hautepierre - Strasbourg
Verified postcode
Strasbourg, France· Recruiting
CHU Tours - Hôpital Trousseau
Verified postcode
Tours, France· Recruiting
Hôpital Paul Brousse
Verified postcode
Villejuif, France· Recruiting

Common questions

What is advanced hepatocellular carcinoma?

Hepatocellular carcinoma is a type of liver cancer. 'Advanced' means the cancer has grown or spread in a way that makes surgery or local treatments difficult or impossible.

What does 'liver transplanted patients' mean?

This refers to people who have previously had a liver transplant – meaning they received a new liver from a donor.

What are Atezolizumab and Bevacizumab?

These are two different medicines that work in different ways to fight cancer. In this study, they are being used together to see if they are more effective.

What is 'acute cellular rejection (ACR)'?

ACR is when your body's immune system tries to attack and reject your transplanted liver. The study is carefully monitoring this risk.

Will my anti-rejection medication change if I join the study?

Yes, part of this study involves carefully adjusting your anti-rejection medicines to try and balance protecting your new liver while allowing the cancer treatment to work.

How to find out more

Manon Allaire, MD

manon.allaire@aphp.fr 142127064 Official trial record

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