This study looks at cholestatic hepatitis, which is a type of liver inflammation that can occur as a side effect in people receiving cancer treatment with medicines called immune checkpoint inhibitors. These cancer treatments work by helping the immune system fight cancer cells, but sometimes they can cause the immune system to attack healthy organs like the liver. When this happens in the liver, it can cause a buildup of substances normally removed by the liver, leading to inflammation. The study will compare two different treatments for this condition: ursodeoxycholic acid, which is a type of bile acid that helps protect the liver and improve bile flow, and corticosteroids, which are medicines that reduce inflammation by calming down the immune system. One of the medications used in the study is prednisone, which is a type of corticosteroid.
The purpose of the study is to see which treatment works better at improving liver function in people who develop this type of liver inflammation after receiving immune checkpoint inhibitors for their cancer. Participants will be randomly assigned to receive either ursodeoxycholic acid or corticosteroids, and both medications will be taken by mouth. The main focus will be on measuring how much the liver function improves after 21 days of treatment by checking blood test results that show liver health.
During the study, doctors will monitor participants for up to 12 months to see if the liver inflammation goes away completely and whether it becomes possible to restart the cancer treatment safely. The study will also track any side effects from the medications and look at different factors that might affect how well the treatment works, such as the type of cancer being treated and how long the person received immune checkpoint inhibitors before developing liver inflammation. Treatment with ursodeoxycholic acid may last up to six months, while treatment with corticosteroids may last up to 12 months depending on how each person responds.
France 
