UDCA vs steroids for immune therapy–induced cholestatic hepatitis
Official title: Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial
Run by University Hospital, Montpellier · NCT07378761 · Data updated 2026-11-12
This study tests whether ursodeoxycholic acid can better help adults with immune therapy–related cholestasis than steroids over 21 days.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 6 sites (Bordeaux and 5 other locations) |
| Status | Recruiting |
| Started | June 25, 2026 |
| Main results expected | January 2028 |
| Study ends | December 2028 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07378761 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with any cancer (excluding hepatocellular and cholangiocarcinoma) who developed grade 3 or 4 ICI-induced cholestatic hepatitis and have not yet started corticosteroids for this condition.
✕Probably not a fit
Patients without UDCA response or those with factors precluding UDCA or corticosteroid use may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 interventional trial compares ursodeoxycholic acid (UDCA) to corticosteroids in adults with cholestatic hepatitis caused by immune checkpoint inhibitors. Participants must have cancer (excluding hepatocellular or cholangiocarcinoma), received at least one ICI, and present grade CTC-AE 3 or 4 cholestasis. The study follows standard treatment and follow-up procedures to assess response over a 21-day period, with a scientific rationale that UDCA may offer similar or superior benefit with better tolerability. MRI and liver biopsy are among the assessment tools, and corticosteroids or UDCA may be discontinued based on safety and response. Recruitment is centered in French centers including Bordeaux, Lyon, and Montpellier.
Why it matters
Potential benefit: If successful, patients may experience improved liver function and symptom relief with UDCA, potentially reducing steroid exposure.
How similar studies have gone: Previous use of UDCA in cholestatic liver diseases supports a rationale, but direct evidence in ICI-induced cholestasis is limited and this trial probes a novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
HCL Croix Rousse
Lyon, France Recruiting -
CHU Montpellier
Montpellier, France Recruiting -
CHU Bordeaux
Bordeaux, France Not yet recruiting -
APHP Paul Brousse
Paris, France Not yet recruiting -
CHU Poitiers
Poitiers, France Not yet recruiting -
CHU Toulouse
Toulouse, France Not yet recruiting
Study contacts
- Principal investigator: Dr. Meunier — University Hospital, Montpellier
- Study coordinator: Dr. MEUNIER
- Email: lucy.meunier@chu-montpellier.fr
- Phone: +33467330224
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.