The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).
The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
247
administration of Sorafenib
administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
Oxaliplatin , fluorouracil, and leucovorin
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou Twelfth People 's Hospita
Guangzhou, Guangdong, China
The Kaiping Center's Hospital
Kaiping, Guangdong, China
Overall survival
Overall survival
Time frame: 6 months
Time to progression
Time to progression
Time frame: 6 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v3.0
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 v3.0
Time frame: 30 days
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First Affiliated Hospital of University Of South China
Hengyang, Hunan, China