Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer
This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
• The pathological diagnosis has confirmed biliary tract malignancy;pathological evidence may be obtained from biopsy/puncture, surgical resection specimens, or a formal pathology report.
• Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed with high-quality cross-sectional imaging, and diagnosed as resectable high-risk biliary malignant tumors, limited to the liver, bile duct and/or regional lymph nodes (at least 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 the liver 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)
• The patient's gender is not limited, and the age is 18-75 years old; Life expectancy\>3 months;
• Within one week of enrollment, the ECOG PS score was 0 or 1;
• No serious complications, such as hypertension, coronary heart disease and psychiatric history, and no serious allergic history; Non pregnancy and non lactation period;
• 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
• The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance.