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.
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
Ongoing corticosteroids treatment
Other causes of hepatitis
Cirrhosis
ICI for hepatocellular carcinoma or cholangiocarcinoma