Ivosidenib in Locally Advanced or Metastatic Cholangiocarcinoma With IDH1 R132 Mutation After at Least One Prior Systemic Treatment - an Observational Study

To be considered for this study, you must be 18 years old or older and have cholangiocarcinoma (bile duct cancer) that has spread or is advanced. It's very important that your cancer has a specific genetic change called an IDH1 R132 mutation, which must have been found through a medical test. You also need to have already received at least one other treatment for your cancer.

Your doctor must have decided that ivosidenib is the right treatment for you based on current medical guidelines. If you choose to take part, you'll need to sign a consent form. If you also decide to take part in the optional part of the study that looks at your quality of life, you'll need to sign that consent before starting the treatment and be able to complete assessments in German.

You cannot join this study if you are already taking part in another clinical trial where you are receiving a specific treatment, or if you have any other medical conditions that would prevent you from safely taking ivosidenib, according to your doctor's assessment.

This is an observational study, which means no new treatments are being given. You would receive ivosidenib as part of your standard medical care, just as your doctor would prescribe it outside of the study. The study involves your medical team collecting information about how you respond to ivosidenib, any side effects you experience, and how the treatment affects your overall well-being. This information would be gathered from your regular hospital visits and check-ups. There might be an optional part of the study where you would be asked to answer questions about your quality of life. The total duration of your participation would depend on how long your doctor determines you need to be on ivosidenib.