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 hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. 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
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Oral Sorafenib, 400mg, Bid
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
administration of Oxaliplatin via the tumor feeding arteries
Dongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGCancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Overall survival
Overall survival
Time frame: 10 months
Progress free survival
Progress free survival
Time frame: 10 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0
Time frame: 30 days
Number of of Patients developed Adverse Events
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.0
Time frame: 30 days
Tumor response
overall response
Time frame: 10 months
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Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China
RECRUITINGKaiping Central Hospital
Kaiping, Guangdong, China
RECRUITINGFirst Affiliated Hospital of University Of South China
Hengyang, Hunan, China
RECRUITINGThe First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
RECRUITING