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 large hepatocellular carcinoma staged BCLC A/B.
Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those with tumor larger than 10 cm. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
315
A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially.
Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.
The First People's Hospital of Foshan
Foshan, Guangdong, China
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou Twelfth People's Hospital
Guangzhou, Guangdong, China
Overall survival
Time frame: 24 months
Time to progression
Time frame: 24 months
Adverse Events
Postoperative adverse events were graded based on CTCAE v4.03
Time frame: 30 Days after HAIC
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 after HAIC
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oxaliplatin,leucovorin and 5-FU
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)