AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efficacy of Ursodeoxycholic Acid versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial

This important study is looking at the best way to treat a specific type of liver inflammation, called cholestatic hepatitis, that can sometimes happen after people receive immunotherapy for cancer. Think of immunotherapy as a treatment that helps your body’s own immune system fight cancer. However, sometimes it can make the immune system overactive and affect organs like the liver. The study is comparing two existing medicines: ursodeoxycholic acid and corticosteroids (a type of steroid). Doctors want to find out which one is more effective at making the liver work better. Specifically, they will measure how many patients show a significant improvement (at least 25%) in their liver function tests within 21 days of starting treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Montpellier

Enrolment target

Start

30 Oct 2025

Cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs)

What is this study about?

When you're undergoing treatment for cancer, especially with newer therapies that boost your immune system (called immunotherapy), sometimes your liver can become inflamed. This condition is called cholestatic hepatitis, and it means your liver isn't working as well as it should, particularly in how it handles bile, a digestive fluid. Doctors are always looking for the safest and most effective ways to manage these side effects so you can continue your cancer treatment if possible, and feel as well as you can.

This study, which is a major phase III trial, focuses on comparing two treatments already used in everyday medicine: ursodeoxycholic acid and corticosteroids (often just called 'steroids'). Both are known to help with liver problems, but doctors aren't sure which one is better for this specific type of liver inflammation caused by immunotherapy. The main goal is to see which medicine helps improve your liver's health the fastest and most effectively. They will be looking for a clear improvement in your liver blood test results, specifically a 25% or more improvement in certain markers, within three weeks of starting the treatment.

Besides how quickly and well your liver recovers, the researchers will also be watching other important things. This includes how long it takes for the liver inflammation to completely clear up, whether you can go back to your immunotherapy treatment after your liver gets better, and what side effects, if any, you might experience from the treatments being studied. They are also curious if certain factors, like the type of immunotherapy you had or whether your bile ducts are swollen, can predict how well you'll respond to either treatment.

Key takeaways

This study compares two treatments for liver inflammation caused by cancer immunotherapy.
The goal is to find out which treatment improves liver function faster and better.
You would receive either ursodeoxycholic acid or corticosteroids.
Liver health will be checked with blood tests, especially after 21 days.
Participation involves regular clinic visits and monitoring for side effects.
This is an important Phase III study, aiming to confirm the best treatment.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

The most important requirement is that you have been diagnosed with cholestatic hepatitis, which is liver inflammation, that has developed because you are receiving or have recently received immunotherapy for cancer. Your doctors will confirm this diagnosis through specific blood tests and possibly other examinations.

There will also be other specific medical criteria that your doctor will check. These might include details about your overall health, other medical conditions you have, and your current medications, to make sure the study treatment is safe and appropriate for you.

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 18 years old or older?
Have you been diagnosed with liver inflammation (cholestatic hepatitis)?
Did this liver problem happen after you started cancer immunotherapy?
Are you able to attend regular clinic appointments for blood tests and monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be randomly assigned to receive one of the two study treatments: either ursodeoxycholic acid or corticosteroids (steroids). This means a computer decides which treatment you get, like flipping a coin, to make the comparison fair. You would take the assigned medication as directed by the study team.

You would have several visits to the clinic, especially at the beginning of the study, to have blood tests to check your liver function and overall health. The main measurement will be taken after 21 days (three weeks) to see how your liver has responded. You will also be monitored for longer periods, up to 6 months and even 12 months, to see if your hepatitis clears up completely and if you're able to resume your original immunotherapy. Any side effects you experience will be carefully recorded by the study team throughout your participation. The total duration of active follow-up will depend on your individual response, but the study will track your health for up to a year.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving close medical monitoring and access to a treatment that might help improve your liver inflammation. However, there are also potential risks, as any medication can have side effects, and the treatment might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and your doctors will discuss all potential benefits and risks specific to your situation.

Locations (1)

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

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Unverified
France

Common questions

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body's immune system fight cancer cells more effectively.

What does 'cholestatic hepatitis' mean?

It means your liver is inflamed, specifically affecting how it handles bile, which is a liquid made by your liver to help digestion.

What are the two treatments being compared?

The study is comparing ursodeoxycholic acid and corticosteroids (a type of steroid medication).

How will doctors know if the treatment is working?

They will mainly look at your blood test results for liver function to see if they improve by at least 25% within 21 days.

Can I choose which treatment I receive?

No, you would be randomly assigned to one of the two treatments, like drawing lots, to ensure the comparison is fair.