Overview
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.
Eligibility
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
