Advanced Hepatocellular Carcinoma (HCC) Clinical Trial
Official title:
Trans-catheter Arterial p53-gene-embolization Using Gelatin Sponge Particles in Treatment of Patients With Advanced Hepatocellular Carcinoma: A Phase II Study
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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