To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (HCC).
In most current guidelines, unresectable HCC with major PVTT are considered not generally suitable for transarterial chemoembolization, and sorafenib is recommended as standard care.3-5 However, for patients with major PVTT, the median overall survival of those treated with sorafenib monotherapy was only 3.1 to 6.0 months. Whether combining sorafenib with hepatic arterial infusion (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 single center, single-arm phase II trial to evaluate the safety and efficacy of sorafenib combined with HAIC in patients with unresectable advanced HCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Oxaliplatin , fluorouracil, and leucovorin
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
progression-free survival rate
Time frame: 3 month
Objective response
Time frame: 3 month
OS
Overall Survival
Time frame: 12 months
AE event
Time frame: 3 months
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