The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor.
The purpose of this study was to explore the safety and efficacy of raltitrexed combined with oxaplatin as second line treatment for advanced malignant biliary system tumor. Single arm,phase II study for patients with cholangiocarcinoma or gallbladder carcinoma after first line treatment failure to explore effection and safety of raltitrexed combined with oxaplatin as second line treatment;Sample size:50.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Raltitrexed combined with oxaplatin as second line treatment of cholangiocarcinoma
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGPFS(Progression Free Survival)
PFS is defined as the time interval from initiation of treatment to the first date of documented tumor progression or death from any cause, whichever occurs first.
Time frame: 24 months
ORR
Overall Response Rate
Time frame: 24 months
OS
Overall Survival
Time frame: 36 months
DCR
Disease Control Rate
Time frame: 24 months
Qol ( quality of life )
EORTC-QLQ-C30 is a cancer-specific instrument
Time frame: 24 months
AE
Adverse Event
Time frame: 12 months
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