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NCT Number: NCT07378761

Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.

The trial presents a detailed scientific justification for comparing UDCA to corticosteroids, describing the treatment and detailing the follow-up procedures. It hypothesizes that UDCA could be superior to corticosteroids for treating ICI-related cholestatic hepatitis, based on its established use in primary biliary cholangitis and a favorable tolerance profile compared to corticosteroids.

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Key information

Conditions

Immune-Mediated Cholestasis Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years old
  • Any type of cancer except hepatocellular or cholangiocarcinoma
  • At least one ICI injection
  • Cholestatic hepatitis Grade CTC-AE 3 or 4

Exclusion criteria

  • Ongoing corticosteroids treatment
  • Other causes of hepatitis
  • Cirrhosis
  • ICI for hepatocellular carcinoma or cholangiocarcinoma
  • Biliary obstruction
  • Medical contraindication to corticosteroids or UDCA
  • Mixed or hepatocellular hepatitis
  • Total bilirubin > 1,5 ULN, Prothrombin rate < 70%
  • Medical contraindication to MRI or liver biopsy
  • Oher serious side effects requiring corticosteroids
  • Pregnant and breast-feeding patients
  • Patients under articles L1121-5 to 8 of the public health code
  • Lack of informed consent
  • Patients not affiliated with French social security system
  • Patients uncapable of understanding french

Treatment and study plan

UDCA (Ursodeoxycholic acid)

Drug

Ursodeoxycholic acid (UDCA) will be administered orally at an initial dose of 13-15 mg/kg/day, divided into two daily doses. After assessment of the primary endpoint at Day 21, UDCA will be continued for a total treatment duration of 6 months. In case of absence of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroids which represent the reference treatment, will be added at a dose of 0.5-1 mg/kg.

Corticosteroids (Reference Treatment)

Drug

Corticosteroids will be administered orally at a dose of 0.5-1 mg/kg/day for 21 days, followed by a tapering schedule of 10 mg per week until treatment discontinuation. At Day 21, if there is no adequate response (defined as less than 25% decrease in alkaline phosphatase and/or gamma-glutamyl transferase from baseline), the corticosteroid taper will continue and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day.

Primary outcomes

  1. Improvement of at least 25% in liver function tests on day 21 after randomization

    Time frame: 21 days after randomization

    The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) on Day 21 after randomization.

Secondary outcomes

  1. Rate of Hepatitis Resolution at 6 Months

    Time frame: 6 Months after randomization

    Rate of patients with resolution of hepatitis, defined as hepatitis grade ≤ 1 according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), at 6 months after randomization.

  2. Time to Hepatitis Resolution

    Time frame: From Randomization to end of follow-up at 12 months

    Time to hepatitis resolution, defined as the time from the date of randomization to the date of hepatitis resolution (grade ≤ 1). Hepatitis severity will be graded according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  3. Tolerance to UDCA and/or Corticosteroids

    Time frame: From treatment initiation following the randomization to end of follow-up at 12 months

    Tolerance to ursodeoxycholic acid (UDCA) and/or corticosteroids will be evaluated through the assessment of adverse events. Adverse events will be collected throughout the study and graded according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  4. Resumption of immunotherapy

    Time frame: Within 12 months after randomization

    Rate of patients in whom resumption of immunotherapy was possible after hepatitis within 12 months after randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. MEUNIER

CONTACT

[email protected]

+33467330224

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: CHILURSO

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 30, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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