Study on the Safety and Effectiveness of Regorafenib and Durvalumab for Treating Advanced Biliary Tract Cancers

Inclusion Criteria

• You or your legal representative must understand the study and be willing to sign a consent form.
• You must be able to swallow tablets and take medication on your own.
• Your cancer must have progressed after at least one previous treatment.
• You should be in good general health, with an activity level that allows you to carry out light work.
• You must have at least one measurable tumor that can be tracked during the study.
• Your cancer must be confirmed as unresectable or metastatic intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer that has progressed after one treatment.
• You should have a life expectancy of at least 3 months.
• You must have recovered from any side effects of previous treatments to a certain level.
• Your organs must be functioning well based on lab tests.
• If you are taking blood thinners, you must have stable blood clotting levels.
• You must weigh more than 30 kg (66 lbs).
• Women who can become pregnant and men with partners who can become pregnant must use effective birth control during the study and for 7 months after the last treatment.
• Men must agree not to donate sperm during the study and for 6 months after the last treatment.

Exclusion Criteria

• You cannot participate in another clinical study with investigational drugs while in this study.
• You should not have any psychiatric or social issues that would prevent you from following the study requirements.
• You cannot be pregnant or breastfeeding.
• You cannot have ampullary carcinoma.
• You cannot have been treated with Regorafenib before.
• You cannot have been treated with certain immune therapies, including Durvalumab, before.
• You cannot have received a live vaccine within 30 days before starting the study drugs.
• You cannot have an active autoimmune disease that required treatment in the past 2 years.
• You cannot have an immune deficiency or be on long-term steroid therapy.
• You cannot have untreated or unstable brain metastases.
• You cannot have severe gastrointestinal disorders with diarrhea.
• You cannot have received cancer treatment within 21 days before starting the study drugs.
• You cannot have any other cancer treatments during the study, except for certain hormonal therapies.
• You cannot have had major surgery within 8 weeks before starting the study drugs.
• You cannot have uncontrolled fluid buildup in the body.
• You cannot have significant bleeding issues within 8 weeks before starting the study drugs.
• You cannot have unresolved side effects from previous cancer treatments, except for certain conditions.
• You cannot have had major surgery recently without complete healing.
• You cannot have a history of organ transplantation.
• You cannot have uncontrolled illnesses, including infections or heart conditions.
• You cannot have uncontrolled high blood pressure.
• You cannot have certain heart rhythm issues.
• You cannot have had a stroke or other serious blood clotting events recently.
• You cannot have had another primary cancer in the last 3 years, with some exceptions.
• You cannot use herbal remedies during the study.
• You cannot have an ongoing infection above a certain severity.
• You cannot have an allergy to any of the study drugs.
• You cannot have severe protein in the urine.
• You cannot have active tuberculosis.
• If you have hepatitis B, you must be on antiviral therapy.
• If you have hepatitis C, you must have a negative test for the virus.