The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with advanced hepatocellular carcinoma (HCC)
Sorafenib is the most widely used palliative treatment for advanced hepatocellular carcinoma (HCC) patients . Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to advanced HCC . However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Oral Sorafenib, 400mg, Bid
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
administration of Oxaliplatin via the tumor feeding arteries
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGGuangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China
RECRUITINGKaiping Central Hospital
Kaiping, Guangdong, China
RECRUITINGProgression Free Survival (PFS)
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
Overall Survival (OS)
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
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Time frame: 12 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 days
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