To evaluate safety and efficacy of combined hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization(TACE)
In most current guidelines, sorafenib is considered as the second-line treatment for patients with transarterial chemoembolization(TACE) failure or refractoriness.However,the median overall survival of those treated with sorafenib monotherapy was 16.4 to 24.7 months. Whether combining sorafenib with hepatic arterial infusion chemotherapy(HAIC) of oxaliplatin,5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective and randomized phase II trial to compare the safety and efficacy of HAIC with sorafenib in patients refractory to TACE
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
administration of Sorafenib
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China
Ming Shi
Guangzhou, Guangdong, China
Kaiping Central Hospital
Kaiping, Guangdong, China
Progression-free survival
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Time frame: 12 months
Overall survival
The period from the date of the start of HAIC or sorafenib until the date of the confirmation of tumor progression or death
Time frame: 12 months
Adverse Events
Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 Days after HAIC and TACE
Objective response rate
Best response based on mRECIST
Time frame: 12 months
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