The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.
Male or female
Age ≥ 18 years，≤ 75 years
Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
Ability to provide written informed consent prior to participation in any study-related procedure
Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
Known history of a serious allergy to any monoclonal antibody
Any active malignancy prior to the start of treatment
Active or history of autoimmune disease
Single group
Total Neoadjuvant Treatment
DrugAdebrelimab (1200 mg) every three weeks intravenously; Mecapegfilgrastim (6 mg) every three weeks intravenously; Gemcitabine (1000 mg/m2) every three weeks on days 1 and 8 intravenously; Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously
Objective response rate (ORR)
ORR is defined as patients achieving clinical complete response (CR) or partial response (PR) according to RECIST v1.1
overall survival (OS)
Overall survival
Progression free survival (PFS)
PFS is defined as time interval from recruitment to tumor progression or censoring
Pathological Complete Response Rate (pCR)
pathological complete response rate
Major Pathological Response Rate (MPR)
MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
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