RecruitingNAINTERVENTIONAL

Liver Transplantation for Locally Advanced Intrahepatic Cholangiocarcinoma After SIRT and Chemotherapy

This study is investigating if a liver transplant can improve survival for people with a specific type of liver cancer called intrahepatic cholangiocarcinoma. This cancer is locally advanced, meaning it's grown within the liver but hasn't spread to other parts of the body, and can't be removed by surgery initially. Participants will first receive special internal radiation therapy (SIRT) and chemotherapy. Doctors will then check if the cancer has responded well enough for a liver transplant. The main goal is to see if this combination of treatments helps patients live longer, specifically looking at survival three years after treatment. The study will include 36 patients from France.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

28 Aug 2025

Estimated completion

01 Oct 2034

Intrahepatic Cholangiocarcinoma Locally Advanced Intrahepatic Cholangiocarcinoma

What is this study about?

This research study is about a type of liver cancer called intrahepatic cholangiocarcinoma. This cancer starts within the liver. Sometimes, the cancer is too advanced to remove with surgery right away, but it hasn't spread to other parts of the body. For these patients, doctors are exploring a new approach.

The main idea behind this study is to see if a liver transplant could be a good treatment option for these patients. But first, to prepare for a possible transplant, patients would receive a special type of internal radiation therapy (called SIRT) along with chemotherapy. The researchers want to find out if this strategy – radiation and chemotherapy followed by a liver transplant – helps people live longer, specifically looking at how many patients are still alive three years after their treatment.

The study aims to involve 36 patients who meet specific criteria. If you have this type of liver cancer, and doctors believe it cannot be operated on right away but hasn't spread, this study could be relevant. It's an important step in trying to find better ways to treat this challenging condition.

Key takeaways

Targets locally advanced intrahepatic cholangiocarcinoma that can't be removed by initial surgery.
Combines special internal radiation (SIRT) and chemotherapy, followed by a liver transplant.
Aims to improve 3-year survival for eligible patients.
Involves detailed health checks and scans to monitor progress.
Planned to include 36 patients from France.

Who may be eligible?

To join this study, people generally need to be between 18 and 65 years old. You must have a confirmed diagnosis of intrahepatic cholangiocarcinoma that is located only in the liver, with no more than 5 small tumours, and doctors must agree that it's not possible to remove the cancer with standard surgery. The cancer needs to be a certain size, and your general health should be good enough to undergo demanding treatments.

There are also reasons why someone might not be able to join. For example, if your liver cancer is a different type or has already spread outside the liver, or if more than half of your liver is affected by the tumour. You also cannot join if you have certain other serious health problems, such as severe heart, kidney, or psychiatric conditions, or if you've had certain other cancers recently. Severe liver scarring (cirrhosis) would also prevent you from participating.

Women who are pregnant or breastfeeding, or anyone currently involved in another medical study that involves an intervention, cannot take part. Everyone who joins must give their full permission and, if they can have children, agree to use effective birth control during and for two years after the study.

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 65 years old?
Do you have intrahepatic cholangiocarcinoma that's confined to your liver (not spread)?
Have doctors said your cancer can't be removed by initial surgery?
Is your general health good enough for major treatments?
Are you able to use effective birth control if you can have children?
Do you have any other serious health conditions that might prevent a liver transplant?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first receive a special type of radiation therapy called SIRT, along with chemotherapy. After these treatments, doctors will do detailed scans (like CT, MRI, and PET-CT) to see how the cancer has responded. If the cancer has improved or hasn't gotten worse, and if other safety checks are met, you might then have exploratory surgery to make sure a liver transplant is safe. Following this, you would be placed on a waiting list for a liver transplant, with a minimum waiting period of three months. After the transplant, you would need regular check-ups to monitor your new liver's health, how well the anti-rejection medicines are working, and your overall well-being. The total duration of your involvement, including follow-up, could extend for a significant period following the transplant.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment approach for your cancer, where standard surgery isn't initially an option, potentially leading to improved survival. However, there are significant risks involved, as both radiation therapy, chemotherapy, and liver transplantation are major medical procedures with potential side effects, complications, and recovery challenges. These can include infections, bleeding, organ rejection after transplant, and reactions to medications. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Beaujon
Verified postcode
Clichy-sous-Bois, France· Recruiting

Common questions

What type of cancer is this study for?

It's for a type of liver cancer called intrahepatic cholangiocarcinoma, which is located in the liver and can't be removed by surgery when first diagnosed.

What treatments will I receive if I join?

You would first have special internal radiation therapy (SIRT) and chemotherapy, followed by a liver transplant if the cancer responds well.

What is the main goal of the study?

The study aims to see if this combination of treatments helps patients with this specific liver cancer live longer, specifically for at least three years.

Where is this study taking place?

Patients will be recruited from medical centres in France.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without it affecting your medical care.

How to find out more

Mohamed BOUATTOUR

mohamed.bouattour@aphp.fr 1.40.87.56.14 Official trial record

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