The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
Department of Interventional Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
RECRUITINGSafety and tolerability, Mortality
Time frame: 6 months
Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival
Time frame: 2 years
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