The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
administration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
administration of gemcitabine and oxaliplatin via vein
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGMing Shi
Guangzhou, Guangdong, China
RECRUITINGOverall survival
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Time frame: 12 months
Progression free survival
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Time frame: 12 months
Time to progression
TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Time frame: 12 months
Number of adverse events.
Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 days
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