Ursodeoxycholic acid for Immune checkpoint inhibitor-induced cholestatic hepatitis

Inclusion criteria

• {"criterion_text":"- Adults, 18 years old with any type of cancer except hepatocellular or cholangiocarcinoma\n- Any therapeutic line (adjuvant or palliative), at least one ICI injection\n- cholestatic hepatitis R≤ 2 (R=ratio (ALT/ULN) /(PAL/ULN)) , Grade CTC-AE 3 or 4.\n- Women of childbearing age using an appropriate contraceptive method throughout the entire duration of the treatment"}

Exclusion criteria

• {"criterion_text":"- Ongoing corticosteroids treatment\n- other causes of hepatitis, cirrhosis\n- ICI for hepatocellular carcinoma or cholangiocarcinoma\n- biliary obstruction\n- medical contraindication to corticosteroids or UDCA medical contraindication to MRI or liver biopsy\n- mixed or hepatocellular hepatitis,\n- total bilirubin > 1,5 ULN, prothrombin rate < 70%\n- other serious side effects requiring corticosteroids\n- patients under articles L1121-5 to 8 of the public health code, lack of informed consent, patients not affiliated with French social security system and patients uncapable of understanding/ reading/ writing in french\n- Pregnant and breastfeeding patients"}

Primary endpoints

• {"endpoint_text":"- The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) from baseline on Day 21.","definition_or_measurement_approach":"Improvement defined as ≥25% decrease from baseline in alkaline phosphatase (PAL) and/or gamma-glutamyl transferase (GGT) measured at Day 21 after randomization."}

Secondary endpoints

• {"endpoint_text":"- Rate of patients with resolution of hepatitis, i.e., grade ≤ 1 according to the current NCI CTC-AE classification, at 6 months after randomization","definition_or_measurement_approach":"Resolution defined as grade ≤1 by NCI CTC-AE at 6 months post-randomization."}
• {"endpoint_text":"- the time to hepatitis resolution (grade ≤ 1) defined as the time from the date of randomization to the date of resolution of hepatitis","definition_or_measurement_approach":"Time from randomization to date when hepatitis reaches grade ≤1 (per NCI CTC-AE)."}
• {"endpoint_text":"- the tolerance to UDCA or corticosteroids or both: Adverse events assessed according to the current NCI-CTC AE classification","definition_or_measurement_approach":"Adverse events collected and graded per current NCI-CTC-AE classification to assess tolerability."}
• {"endpoint_text":"- Factors associated with response to UDCA at D21 among the immunotherapy molecule, duration of ICI treatment, presence or absence of bile duct dilation, tumor histology","definition_or_measurement_approach":"Analysis of clinical and treatment-related factors (ICI agent, duration of ICI, bile duct dilation, tumor histology) associated with response to UDCA at Day 21."}
• {"endpoint_text":"- Rate of patients in whom resumption of immunotherapy was possible after hepatitis within 12 months after randomization","definition_or_measurement_approach":"Proportion of patients able to resume immunotherapy within 12 months post-randomization."}

France

Earliest CTIS Part Ii Submission Date

06-10-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

42

Number Of Sites

6

Number Of Participants

94

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France