A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

Inclusion Criteria:

1. both men and women, age ≥ 18 years old；
2. A histopathological or cytological diagnosis of gallbladder cancer and extrahepaticcholangiocarcinoma after radical resection
3. Postoperative pathological stage is T2-4 or N1 R0/R1 resection；
4. No more than 12 weeks from radical resection；
5. Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
6. Estimated life expectancy >6 months;
7. Biliary drainage is in good condition, no current infection ;
8. Have not received radiotherapy, chemotherapy, or immunotherapy for the primary tumor;
9. The function of important organs meets the following requirements:

(1) Blood routine test: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L,hemoglobin ≥100g/L; (2) Biochemical tests : ALT, AST ≤ 2.5×ULN; ALB≥ 35g/L;total bilirubin ≤3×ULN; serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥50 mL/min(Crockcroft-Gaultformula); 10.Subjects voluntarily joined the study, signed an informed consent form, hadgood compliance, and cooperated with the follow-up.

Exclusion Criteria:

1. Local recurrence or distant metastasis (including ascites or malignant pleuraleffusion);
2. Severe cardiovascular disease, such as New York Heart Association (New York HeartAssociation, NYHA standard) heart failure above grade 2, unstable angina, unstablearrhythmia, or color photos of the heart suggest LVEF (left ventricular ejectionfraction) )<50%;
3. Known allergy or hypersensitivity to monoclonal antibodies or fluorouracil drugs ortheir analogues;
4. Subjects with known, active or suspicious autoimmune diseases, who are in a stablestate and do not require systemic immunosuppressive therapy can be included in thegroup;
5. Subjects were treated with immunosuppressants or systemic or absorbable topicalcorticosteroids within 2 weeks before the first study to achieve immunosuppressivepurposes (>10mg/day prednisone or equivalent dose) ;
6. Suffered from other active malignancies within 5 years before the first administrationof the study drug. Cured localized tumors, such as skin basal cell carcinoma, skinsquamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ,cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in thegroup;
7. Active viral hepatitis (such as hepatitis B, hepatitis C, unless antiviral treatmentis given and the HBV or HCV viral load is below the minimum detection limit can beconsidered for inclusion), HIV positive or a known history of acquiredimmunodeficiency syndrome ；
8. Any active infection that requires systemic anti-infective treatment occurs within 14days before the first medication;
9. Have active tuberculosis in the past 1 year, regardless of treatment;
10. Live attenuated vaccines have been used within 28 days before screening;
11. Subjects who have previously received allogeneic bone marrow transplantation or solidorgan transplantation;
12. Have received any other experimental drug treatment within 28 days before signing theICF;
13. People who have difficulty swallowing or have known drug absorption disorders;
14. Women who are pregnant or breastfeeding;
15. Subjects of childbearing age who refuse to use effective contraceptive measures;
16. Situations that other researchers think are not suitable for inclusion. -