Phase II study of second line capecitabine plus oxaliplatin (XELOX) in patients with advanced biliary tract carcinoma after failure of gemcitabine-based chemotherapy.
XELOX * Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks * Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Samsung Medical Center
Seoul, South Korea
RECRUITINGProgression-free survival
Time frame: 12months
response rate
Time frame: 12months
duration of response
Time frame: 12months
overall survival
Time frame: 12months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24months
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