IBI310 in Combination With Sintilimab in Patients With Advanced Biliary Tract Cancer

Inclusion Criteria:

1. The subject must sign the written informed consent form, and can comply with thevisits and related procedures specified in the protocol.
2. Aged ≥18 years.
3. Patients with unresectable or relapsed or metastatic advanced Biliary tract cancer,anddiagnosed by histology/cytology (except carcinoma of ampulla).
4. Had progressed after receiving at least first-line systemic treatment (if a patienthas progressed within 6 months after receiving systemic treatment during adjuvantchemotherapy or concurrent radiochemotherapy, she will be deemed to have receivedfirst-line treatment).
5. Patients who have never received any anti-PD-1, anti-PD-L1/L2 antibody, anti-CTLA-4antibody, or other immunotherapy.
6. The subject must have at least one measurable lesion as the target lesion (accordingto RECIST V1.1). A measurable lesion in the radiation field from previous radiotherapyor local treatment, can also be chosen as the target lesion if confirmed progression.

Exclusion Criteria:

1. Diagnosis of other malignant tumors within 5 years before the first administration,excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma,radically resected carcinoma in situ and/or thyroid papillary carcinoma.
2. Patients who have previously received organ or bone marrow transplantation.
3. Patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA> 2000 IU/ml or 104 copies/ml; hepatitis C virus (HCV) antibody positive andHCV-RNA >103 copies/ml;. Patients with acute or chronic active hepatitis B or Cinfection who have received nucleotide antiviral therapy and are below the abovestandards can be selected.
4. Uncontrollable hypertension, systolic blood pressure ≥150 mmHg or diastolic bloodpressure ≥100 mmHg after best medical treatment, history of hypertensive crisis orhypertensive encephalopathy.
5. Pleural effusion, ascites, and pericardial effusion with clinical symptoms orrequiring drainage , patients who only shows with a few pleural effusion, ascites, andpericardial effusion by imaging and with no clinical symptoms can be selected.