To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.
chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
286
oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2 every three weeks for 6-8 cycles in total.
capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRecurrence-free survival
Time frame: from the date of surgery to the date of tumor recurrence up to 36 months after surgery
Overall survival
Time frame: from the date of surgery to the date of death up to 36 months after surgery
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