RecruitingOBSERVATIONAL

Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids

This study is investigating a new way to treat liver inflammation, called hepatitis, which can sometimes happen to cancer patients receiving immunotherapy (checkpoint inhibitors). These powerful cancer drugs can sometimes cause the immune system to overreact and affect healthy organs like the liver. Usually, high doses of steroids are given to calm the immune system, but these can have many side effects. This study aims to see if a lower dose of a steroid called prednisolone (0.5-1mg per kg of body weight) can effectively manage this liver problem. The main goal is to find out if this lower dose can help patients recover quickly, avoid stronger treatments, and reduce the side effects often seen with higher steroid doses, all while keeping the cancer treatment effective.

At a glance

Status

Recruiting

Sponsor

University Hospital, Basel, Switzerland

Enrolment target

Start

25 Aug 2025

Estimated completion

31 Dec 2026

What is this study about?

Immunotherapy is a revolutionary type of cancer treatment that helps your body's own immune system fight cancer cells. While often very effective, these powerful treatments can sometimes cause side effects known as 'immune-related adverse events' (irAEs). One of these can be inflammation of the liver, called hepatitis. This happens because the boosted immune system sometimes mistakenly attacks healthy liver cells.

Currently, if you develop this liver inflammation, doctors often prescribe steroid medications to calm your immune system. However, high doses of steroids can come with their own set of unwanted side effects, like an increased risk of infections, changes in blood sugar, or mood swings. This study wants to find out if a smaller dose of steroids, specifically prednisolone (0.5 to 1 milligram per kilogram of your body weight), can be just as effective in treating this liver problem. The idea is that a lower dose might still work well, but with fewer side effects, making your treatment journey smoother.

The researchers will be looking closely at how patients respond to this lower steroid dose. They want to see if your liver function improves quickly, if you avoid needing higher steroid doses or additional strong immune-suppressing drugs, and if the overall cancer treatment remains effective. By using this 'test dose' approach, they hope to minimise the impact of side effects from the treatment for liver inflammation, without compromising your recovery or the ongoing fight against your cancer.

Key takeaways

This study explores using lower steroid doses for liver inflammation from cancer immunotherapy.
It aims to reduce steroid side effects while keeping treatment effective.
Patients with moderate to severe liver inflammation from immunotherapy may be eligible.
Close monitoring of liver function will be a key part of participating.
The study hopes to find safer ways to manage immunotherapy side effects.

Who may be eligible?

This study is looking for adults aged 18 or older who are currently receiving a specific type of immunotherapy for cancer. You might be suitable if you develop moderate to severe liver inflammation (grade 2 or 3 hepatitis) as a side effect while on this treatment.

However, there are certain situations where you might not be able to join. For example, if you've had this liver problem before and needed strong treatment, or if your liver issue is very severe (grade 4) right from the start. Also, if you have other serious immune-related problems affecting your brain or heart that need high doses of steroids, this study wouldn't be right for you.

Additionally, if you have other known liver conditions (like certain types of hepatitis or advanced liver disease) or are receiving other cancer treatments at the same time that could affect your liver, you would likely not be able to participate. The study aims to make sure participants are able to safely follow the study plan for managing their liver inflammation.

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 or older?
Are you currently receiving immunotherapy for cancer?
Have you developed moderate (grade 2) or severe (grade 3) liver inflammation as a side effect?
Have you NOT received high-dose steroids for this problem before joining?
Do you NOT have other serious immune side effects (like brain or heart issues) needing high-dose steroids?
Do you NOT have certain other pre-existing liver conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would begin treatment for your liver inflammation with a low dose of prednisolone, a type of steroid. Your medical team will closely monitor your liver function through regular blood tests. They will assess how well the low-dose steroids are working to calm the inflammation. The main aim is for your liver function to return to normal or near-normal levels within 8 weeks, without needing to increase the steroid dose or add other strong medications. During this time, your steroid dose would gradually be reduced. The study will track your progress, including how quickly your liver recovers, the total amount of steroids you take, and if the inflammation comes back. The exact number of visits and follow-up tests would be explained to you by the study team, but generally, it involves careful monitoring while you’re receiving your cancer treatment and managing this side effect.

Potential risks and benefits

Participating in this study might offer the potential benefit of managing your liver inflammation with a lower dose of steroids, which could mean fewer side effects compared to standard higher doses. This could make your overall treatment experience more comfortable while still ensuring your liver gets better. However, there's always a possibility that the lower steroid dose might not be enough for your specific case, and you might need additional or higher-dose treatments. There could also be other, unexpected risks associated with any medical treatment. Your doctors will monitor you very closely for any issues. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (2)

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

University Hospital Basel
Verified postcode
Basel, Switzerland· Recruiting
Royal Marsden Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is 'immune checkpoint inhibition-related hepatitis'?

It's when your immune system, boosted by cancer immunotherapy, accidentally causes inflammation in your liver.

What are corticosteroids?

They are steroid medications that help calm down an overactive immune system and reduce inflammation.

Why use 'low-dose' steroids?

The study wants to see if a smaller dose can be just as effective as higher doses, but with fewer side effects like infections or mood changes.

How long will the treatment for hepatitis last?

The study aims for your liver function to improve within 8 weeks, with your steroid dose gradually reduced during this time.

Will this affect my cancer treatment?

The goal is to manage the liver inflammation effectively without negatively impacting the effectiveness of your ongoing cancer immunotherapy.

How to find out more

Andreas M Schmitt, MD

andreasmichael.schmitt@usb.ch +41 61 265 50 74 Official trial record

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