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.

Inclusion Criteria:

• histopathologically diagnosed unresectable HCC
• over 18 years old
• with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
• with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
• with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
• signed the informed consent form.

Exclusion Criteria:

• hypersensitive to study drug
• With an abnormal coagulation condition or bleeding disorder
• infections
• with serious conditions which prevent using the study treatment
• pregnant or lactating