An open-labeled, randomized, active-controlled phase II study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (TAE) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (HCC).
Treatment options for advanced HCC are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) is a safe locoregional treatment for advanced HCC and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. The objectives of this study are to investigate clinical efficacy and immunoreaction usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
Trans-catheter embolization
first affiliated hospital in Dalian University
Dalian, Liaoning, China
RECRUITINGoverall survival
overall survival will be follow up to 2 years
Time frame: 2 years
immuno-reaction (lymphocyte counts and subgroup ratios)
The immune reaction after study treatment will be assessed every one week until 3 months after the first treatment
Time frame: 3 months
progression free survival
Time frame: 2 years
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