This is an open-label,single center,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 postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
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;
Unresectable PHC patients or postoperative diagnosis of PHC recurrence and metastasis ;
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;
Single group
PD-1antibody plus GEMOX
Drug1. PD-1 antibody，200mg，D1，intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1，D8；oxaliplatin 100mg/m2,D1，intravenous infusion. 3. Three weeks is a course of treatment,a total of 6-8 courses.
The 12-month relapse-free survival rate
Relapse-free survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
The 12-month overall survival rate
Overall survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
The 60-month overall survival rate
Overall survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
Relapse-free survival
RFS is defined as the time from resection to relapse or death from any cause, whichever occurred first.
Overall survival
OS is defined as the time from resection to death from any cause.
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