drugset / Trial / NCT02418988

Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma

NCT02418988 ↗

Phase 2 Unknown 120 enrolled Shenzhen SiBiono GeneTech Co.,Ltd
RandomizedParallel-groupOpen-labelPrevention

Summary

Treatment options for advanced hepatocellular carcinoma (HCC) are limited due to patients' poor condition, advanced tumor, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. Trans-catheter embolization (TAE) or Trans-catheter chemo-embolization (TACE) is the most widely used locoregional treatment for advanced HCC. But no solid evidences support the beneficial effect of the chemotherapy in TACE. Many advanced HCC patients also can't tolerate the locoregional chemotherapy. The p53 gene has multiple anticancer functions and does not have any of the immune-inhibitory effects of chemo- or radio-therapy. The objectives of this study are to investigate the efficacy and safety usingTAE plus recombinant adenoviral human p53 gene (rAd-p53) in treatment of advanced HCC.

Timeline

Start
2014-07
Primary completion
2017-05
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject rAd-p53 Unknown 2e+12 vg Other