Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer

Inclusion Criteria:

1. Confirmed as malignant tumor of biliary tract by pathological diagnosis;
2. Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed withhigh-quality cross-sectional imaging, and diagnosed as resectable high-risk biliarymalignant tumors, limited to the liver, bile duct and/or regional lymph nodes (atleast one of the following criteria must be met) :

• T-stage ≥ Ib (Ib-IV)
• Solitary lesion > 5 cm
• Multifocal tumors or satellite lesions present confined to the same lobe of theliver as the dominant lesion but still technically resectable
• Presence of major vascular invasion but still technically resectable
• Suspicious or involved regional lymph nodes (N1)
• No distant extrahepatic disease (M0)

3. The patient's gender is not limited, and the age is 18-75 years old; Life expectancy>3months;
4. Within one week of enrollment, the ECOG PS score was 0 or 1;
5. No serious complications, such as hypertension, coronary heart disease and psychiatrichistory, and no serious allergic history; Non pregnancy and non lactation period;
6. The patient's organ and blood system functions meet the requirements:

• Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
• Platelet count ≥ 100 × 10^9/L
• Hemoglobin ≥ 90 g/L
• Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN
• Albumin ≥ 3g/dL
• Creatinine ≤ 1.5 x ULN

7. The patient can understand and sign the informed consent form to participate in thetrial study; can follow up with good compliance.

Exclusion Criteria:

1. Patients who received PD-1, PD-L1, PD-L2, CTLA-4 inhibitors before enrollment, orpatients who directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, CD137);
2. Used any other research drugs within 4 weeks before enrollment;
3. Any active autoimmune disease or history of autoimmune disease (such as interstitialpneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis,nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy);Patients with childhood asthma who have completely alleviated and do not need anyintervention or leukorrhea after adulthood can be included, but patients who needmedical intervention with bronchodilators cannot be included;
4. With congenital or acquired immune deficiency, such as people infected with humanimmunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit ofthe analytical method) or people with hepatitis B and hepatitis C co infection;
5. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviraldrugs) occurred within 4 weeks before the first drug administration, or fever ofunknown cause>38.5 ° C occurred during screening/before the first drug administration;
6. History of allogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation;
7. Test drug allergy;
8. Suffering from uncontrollable mental illness;
9. Peripheral neuropathy of grade 2 or above according to CTCAE 4.0. In CTCAE 4.0, grade 2 sensory neuropathy is defined as "moderate symptoms; restriction of activities ofdaily living (ADL)";
10. Occurrence of serious and/or uncontrollable diseases at the same time may affectparticipation in the study, such as unstable angina, myocardial infarction within 6months, unstable symptomatic arrhythmia, symptomatic congestive heart failure,diabetes out of control, severe activity, uncontrollable infection after inadequatebiliary drainage (such as tumor blocking the bile duct), or mental disease/socialcondition;
11. Pregnancy (positive pregnancy test) or lactation;
12. Diseases of central nervous system (CNS), except for brain metastasis treated. Thetreated brain metastatic tumor is defined as confirmed by clinical examination andbrain imaging (MRI or CT) during the screening period, and there is no sign ofprogress or bleeding after treatment, and there is no need for continuous applicationof dexamethasone. Anticonvulsant drugs (stable dosage) are allowed. The treatment ofbrain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gammaknife, linear accelerator [LINAC] or equivalent) or a combination deemed appropriateby the treating doctor. Patients with central nervous system metastasis who underwentneurosurgical resection or brain biopsy within 3 months before the first day wereexcluded;
13. Other cancers in the past (within the past 5 years) or at the same time, excluding nonmelanoma skin cancer and carcinoma in situ;
14. History of allergy or hypersensitivity to any study drug;
15. Current abuse of alcohol or illicit drugs;
16. Unable or unwilling to sign the informed consent form.