Testing Mitazalimab in Combination With Standard Chemotherapy in Immunotherapy Resistant Advanced Biliary Tract Cancers

To join this study, you would generally need to be at least 18 years old and have been diagnosed with a specific type of bile duct cancer (intrahepatic, extrahepatic, or gallbladder cancer). The cancer should be advanced, meaning it cannot be removed by surgery, has spread, or has come back after surgery more than six months ago. You would also need to have already received a standard first round of chemotherapy for your bile duct cancer and be suitable for treatment with mFOLFOX.

There are also some important health requirements. Your body's systems, like your blood, kidneys, and liver, need to be working well enough to safely receive the treatments. This will be checked with blood tests. If you are a woman who could become pregnant, you would need to have a negative pregnancy test and agree to use effective contraception. Men would also need to use contraception during and for a period after the study.

Lastly, you must be covered by a health insurance system (like the NHS in the UK) and be able to give your informed consent, which means understanding and agreeing in writing to take part in the study.

If you decide to take part in this study, you will either receive mFOLFOX chemotherapy every two weeks, or mFOLFOX chemotherapy plus Mitazalimab. If you receive Mitazalimab, you'll have your first injection 7 days before your first mFOLFOX chemotherapy, and then 3 days after each mFOLFOX cycle.

You will visit the clinic every two weeks for check-ups and tests. This allows the medical team to monitor your health and how you're responding to the treatment. Every 8 weeks while you are on treatment, you will have scans to see how the cancer is reacting. If your treatment stops, you will continue to have follow-up visits and scans at the hospital. These will be every 8 weeks if your cancer hasn't progressed, or every 12 weeks after your cancer has progressed.