The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. Our previous prospective study also revealed that TACE confers a survival benefit to patients with HCC and portal venous tumor thrombus (PVTT). Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for patitens with BCLC stage C 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
214
infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
Dongguan People's Hospital
Dongguan, Guangdong, China
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou Twelfth People 's Hospital
Guangzhou, Guangdong, China
Overall survival
Overall survival
Time frame: 18 months
Progress free survival
Progress free survival
Time frame: 18 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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Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Oral Sorafenib, 400mg, Bid
Kaiping Central Hospital
Kaiping, Guangdong, China
The First Affiliated Hospital of University Of South China
Hengyang, Hunan, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China