It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGPFS
PFS is defined as time from the start of treatment to progression of disease or death.
Time frame: up to 3 years
ORR
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Time frame: up to 3 years
OS
Overall survival is defined as time from the start of treatment until death due to any reason.
Time frame: up to 3 years
TTP
Time to progress is defined as time from randomized grouping to objective progression of tumors.
Time frame: up to 3 years
AEs
Adverse reactions refer to the occurrence and development of diseases in the process of using drugs according to normal usage and dosage to prevent, diagnose or treat diseases.Adverse reactions unrelated to the purpose of treatment.
Time frame: up to 3 years
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