The study is a phase II clinical trial of single arm. The purpose is to evaluate the safety and efficacy of anti-PD-1 antibody Toripalimab combined with chemotherapy(gemcitabine+5-fluorine pyrimidine) in unresectable advanced cholangiocarcinoma patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
3mg/kg on d1 and d15 q4W\*4cycles，then 3mg/kg q3w for 1 year in total
1250mg/m2 on d1 and d15 q4W\*4cycles
400mg/m2 intravenous injection plus 5-FU 2.4g-3.6g/m2 continuous intravenous drip for 48h on d1 and d15 q4W\*4cycles
Jiangmen central hospital
Jiangmen, Guangdong, China
RECRUITING6-month PFS rate
the rate of 6-month progression free survival
Time frame: 6-month after the beginning of first line systemic therapy
mPFS
the median of progression free survival
Time frame: from the beginning of the first line systemic therapy until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 24 months
Toxic side effects
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
Time frame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
ORR
the objective response rate
Time frame: from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
DCR
the disease control rate
Time frame: from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
1-year OS rate
the rate of 1-year overall survival
Time frame: 1 year after the beginning of the first line systemic therapy
mOS
the median of overall survival
Time frame: from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months
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