Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer

Inclusion criteria

• ✓. Capable of giving written informed consent, including participation in optional translational research if applicable, and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• ✓. Histologically proven and curatively resected biliary tract cancer (intrahepatic, hilar or distal CCA as well gallbladder carcinoma) without metastatic disease, in the adjuvant situation (R0/R1) up to 16 weeks from surgery.
• ✓. Men or women\* ≥ 18 years at time of study entry.
• ✓. Performance status (PS) ≤ 1 (ECOG scale),with no deterioration over the previous two weeks prior to baseline.
• ✓. Must have a life expectancy of at least 12 weeks
• ✓. Appropriate hematological, hepatic and renal function:
• ✓. Adequate coagulability, as determined by the International Normalized Ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 5 seconds above the UNL (unless anti-coagulation therapy has been given). Patients receiving warfarin / phenoprocoumon must be switched to low molecular weight heparin and before starting study-specific procedures.
• ✓. Patients of reproductive age must be prepared to use a suitable contraceptive method during the study and up to 3 months after the end of treatment. A suitable method of contraception is defined as surgical sterilization (e.g., bilateral fallopian tube ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double barrier methods (each two-fold combination of intrauterine pessary, condom for men, or women with spermicidal gel, Diaphragm, contraceptive sponge, cervical cap). Women of child-bearing potential must have a negative serum pregnancy test within the last 7 days prior to the start of study therapy.

Exclusion criteria