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Comparing Ursodeoxycholic Acid and Prednisone for Treating Liver Inflammation Caused by Cancer Immunotherapy in Adult Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at cholestatic hepatitis, which is a type of liver inflammation that can occur as a side effect in people receiving cancer treatment with medicines called immune checkpoint inhibitors. These cancer treatments work by helping the immune system fight cancer cells, but sometimes they can cause the immune system to attack healthy organs like the liver. When this happens in the liver, it can cause a buildup of substances normally removed by the liver, leading to inflammation. The study will compare two different treatments for this condition: ursodeoxycholic acid, which is a type of bile acid that helps protect the liver and improve bile flow, and corticosteroids, which are medicines that reduce inflammation by calming down the immune system. One of the medications used in the study is prednisone, which is a type of corticosteroid.

The purpose of the study is to see which treatment works better at improving liver function in people who develop this type of liver inflammation after receiving immune checkpoint inhibitors for their cancer. Participants will be randomly assigned to receive either ursodeoxycholic acid or corticosteroids, and both medications will be taken by mouth. The main focus will be on measuring how much the liver function improves after 21 days of treatment by checking blood test results that show liver health.

During the study, doctors will monitor participants for up to 12 months to see if the liver inflammation goes away completely and whether it becomes possible to restart the cancer treatment safely. The study will also track any side effects from the medications and look at different factors that might affect how well the treatment works, such as the type of cancer being treated and how long the person received immune checkpoint inhibitors before developing liver inflammation. Treatment with ursodeoxycholic acid may last up to six months, while treatment with corticosteroids may last up to 12 months depending on how each person responds.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon entering the study, you will be randomly assigned to one of two treatment groups. This means that a computer system will determine whether you receive ursodeoxycholic acid or corticosteroids.

    Random assignment ensures that the comparison between the two treatments is fair and unbiased.

  2. Step 2

    Beginning of treatment

    You will begin taking the medication assigned to your group. The treatment will be administered by mouth.

    If you are assigned to the ursodeoxycholic acid group, you will receive this medication according to the dosing schedule determined by the study doctor.

    If you are assigned to the corticosteroid group, you will receive prednisone in tablet form. The specific product is CORTANCYL 20 mg, which is a divisible tablet taken by mouth.

    The study doctor will provide you with detailed instructions on how to take your assigned medication, including the exact dose and frequency.

  3. Step 3

    Treatment period up to day 21

    You will continue taking your assigned medication for a period of 21 days.

    During this time, your liver function will be monitored through blood tests that measure alkaline phosphatase and gamma-GT. These are enzymes that indicate how well your liver is working.

    The main goal of this period is to determine whether your liver function improves by at least 25% compared to the start of treatment.

  4. Step 4

    Assessment on day 21

    On day 21, your liver function tests will be evaluated to determine if there has been an improvement of at least 25% in alkaline phosphatase and/or gamma-GT levels.

    This assessment is the primary measure of whether the treatment is working for you.

  5. Step 5

    Continued monitoring and follow-up

    After the initial 21-day treatment period, you will continue to be monitored for up to 6 months after your random assignment.

    During this time, blood tests will be performed to check whether your liver inflammation has resolved. Resolution is defined as your liver function returning to a mild level or normal according to standard medical classifications.

    The study team will also monitor any side effects you may experience from the medication.

    The time it takes for your liver inflammation to resolve will be recorded.

  6. Step 6

    Extended follow-up period

    You will be followed for up to 12 months after your random assignment.

    During this extended period, the study team will assess whether it becomes possible for you to resume your cancer immunotherapy treatment.

    This long-term follow-up helps determine the overall impact of the treatment on your ability to continue with your cancer therapy.

  7. Step 7

    Safety monitoring throughout the study

    Throughout your participation in the study, any side effects or adverse events will be carefully recorded and assessed according to standard medical classifications.

    This monitoring applies to both ursodeoxycholic acid and corticosteroids, as well as any combination of treatments you may receive.

    If you experience any unusual symptoms or side effects, these will be documented and managed appropriately.

Who can join the trial?

5 criteria

  • You must be an adult, 18 years old or older
  • You must have any type of cancer, except for hepatocellular cancer (a type of liver cancer) or cholangiocarcinoma (a cancer of the bile ducts, which are tubes that carry digestive fluid)
  • You must be receiving treatment at any stage, either as adjuvant therapy (treatment given after the main treatment to lower the risk of cancer returning) or palliative therapy (treatment to relieve symptoms and improve quality of life), and you must have received at least one injection of an immune checkpoint inhibitor (a type of cancer treatment that helps your immune system fight cancer)
  • You must have cholestatic hepatitis (inflammation of the liver with problems in bile flow) with specific laboratory values showing R less than or equal to 2, where R is calculated using blood test results for ALT (a liver enzyme) and alkaline phosphatase (another liver enzyme) compared to their normal upper limits, and this condition must be Grade 3 or 4 in severity according to CTC-AE (a standard scale used to measure side effects)
  • If you are a woman who can become pregnant, you must use an appropriate contraceptive method (birth control) throughout the entire duration of the treatment

Who cannot join the trial?

3 criteria

  • The study does not list any specific reasons why patients cannot participate in this clinical trial
  • However, you should always discuss with your doctor whether this study is appropriate for your individual medical situation
  • Your doctor will review your complete medical history and current health condition to determine if participation is safe for you
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Investigated drugs

  • Ursodeoxycholic acid

    is a medication used to treat liver problems. It helps protect liver cells and improve the flow of bile, which is a fluid made by the liver that helps digest fats. In this trial, it is being tested to see if it can treat liver inflammation caused by cancer immunotherapy treatments.

  • Corticosteroids

    are medications that reduce inflammation and calm down the immune system. They are commonly used to treat many conditions where the body's immune system is causing damage to organs or tissues. In this trial, they are being compared to ursodeoxycholic acid to see which works better for treating liver inflammation caused by cancer immunotherapy treatments.

What is already known about the treatment

  • Ursodeoxycholic Acid

    Ursodeoxycholic acid is a medication typically taken by mouth in tablet or capsule form that is well-established in medical practice for treating various liver and bile duct conditions. In this clinical trial, it is being studied as a potential treatment for liver inflammation with reduced bile flow that occurs as a side effect of cancer immunotherapy drugs. The medication works by protecting liver cells and improving bile flow through changing the composition of bile acids in the body, making them less toxic to liver tissue. It belongs to a class of drugs called bile acids or cholagogues, which are substances that promote the flow of bile from the liver.

  • Corticosteroids

    Corticosteroids are anti-inflammatory medications that can be given in various forms including tablets, injections, or intravenous infusions, and are widely used in modern medicine to treat immune-related conditions and inflammatory diseases. In this study, they serve as the comparison treatment for managing liver inflammation caused by cancer immunotherapy medications. These drugs work by suppressing the immune system and reducing inflammation at the cellular level by blocking the production of substances that trigger inflammatory responses in the body. Corticosteroids belong to a pharmacological class called immunosuppressants and anti-inflammatory agents, which reduce the activity of the body's immune system.

Investigated diseases

Cholestatic Hepatitis Induced by Immune Checkpoint Inhibitors – This is a liver condition that occurs as a side effect of cancer treatment with immune checkpoint inhibitors, which are medications that help the immune system fight cancer. The disease causes inflammation of the liver with a specific pattern called cholestasis, meaning that bile flow from the liver is reduced or blocked. Patients develop elevated levels of certain liver enzymes, particularly alkaline phosphatase and gamma-GT, which indicate liver damage. The condition can progress over time if left untreated, with liver inflammation potentially worsening. The severity of the disease is classified using a grading system, with higher grades indicating more serious liver involvement. This type of hepatitis is directly linked to the use of immune checkpoint inhibitors and represents an immune-related adverse reaction to these cancer therapies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521317-50-00Estimated enrolment94 patientsSponsorCentre Hospitalier Universitaire De Montpellier

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