The purpose of the study is to determine whether transarterial chemoembolization containing arsenic trioxide is safe and effective in the treatment of intermediate-stage hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Xijing Hospital,Fourth Military Medical University
Xi'an, Shaanxi, China
time to progression
Time frame: From date of randomization until the date of first documented progression, up to 24 months
objective response rate
patients proportion of CR and PR according to mRECIST
Time frame: every 3 months from randomization until the date of first documented progression, up to 24 months
progression free survival
survival from randomization to the date of first documented progression according to the mRECIST criterion
Time frame: From date of randomization until the date of first documented progression, up to 24 months
overall survival
Time frame: From date of randomization until the date of death from any cause, up to 60 months
Proportion of Participants with Adverse Events
Time frame: every 3 months from randomization until the date of first documented progression, up to 24 months
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Zhongshan Hospital Fudan University
Shanghai, China