Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

To be considered for this study, you must be 18 years or older. You need to have been diagnosed with cholangiocarcinoma (bile duct cancer) that has spread or can't be removed with surgery. Importantly, your cancer must have a specific genetic change called an 'FGFR2 fusion/rearrangement', and your doctors will need to confirm this. You must have already tried at least one type of chemotherapy and exactly one FDA-approved FGFR inhibitor medicine, but these treatments haven't worked well enough or your cancer has returned.

There are also some reasons why you might not be able to join. For example, if you've already had two or more FGFR inhibitor drugs, or if your cancer has spread to your brain and is getting worse quickly. You also can't have another type of cancer that is active and needs treatment, unless it's a very minor skin cancer or a specific type of cervical cancer. Doctors will also check that you've recovered from any serious side effects of your previous treatments before starting a new medicine in the study.

If you join this study, you will be assigned to one of three groups. Two groups will receive Tinengotinib, either as an 8 mg tablet or a 10 mg tablet, once a day. The third group will receive a treatment chosen by your doctor. You won't be able to choose which group you are in, as this is decided randomly, like flipping a coin. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. The study will continue for as long as the treatment is helping you and you are tolerating it well. After you stop taking the study drug, there will be some follow-up appointments to check on your long-term health.