This is an open-label,multicenter ,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as preoperative translational therapy for unresectable gallbladder cancer.
The patient must sign an informed consent form;
Age 18-75 years old, both male and female;
ECOG performance status score (PS score) 0 or 1 point;
Child-Pugh score A period;
Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary carcinoma;
Have used gemcitabine-based chemotherapy or have used PD-1 monoclonal antibody or PD-L1 monoclonal antibody treatment within 6 months;
Severe cardiopulmonary and renal dysfunction;
Hypertension that is difficult to control with drugs (systolic blood pressure (BP) ≥140 mmHg and/or diastolic blood pressure ≥90mmHg) (based on the average of ≥3 BP readings obtained by ≥2 measurements);
Single group
Carrilizumab plus GEMOX
DrugPD-1 antibody，200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1，D8；oxaliplatin 100mg/m2,D1intravenous infusion.Three weeks is a course of treatment.
Radical resection rate
The proportion of patients whose tumors converted to a surgically resectable state and achieved radical resection within 8 courses of medication in all patients enrolled.
Objective response rate (ORR)
Complete response (CR) and partial response (PR), at 6 months by RECIST v.1.1
Disease control rate(DCR)
Complete response (CR) ,partial response (PR) and stable disease, SD, at 6 months by RECIST v.1.1
Progression-free survival (PFS)
The time from first drug administration to the first documented disease progression according to RECIST version 1.1 or to death from any cause, whichever occurred first.
Overall survival(OS)
The time from first drug administration to death from any cause.
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