Phase II Study of Bronchial Arterial Infusion of P53 Gene in Treatment of Multiple Lung Metastases of Hepatocellular Carcinoma

Objectives: To explore efficacy and safety of bronchial arterial infusion of recombinant adenovirus p53 gene (rAd-p53, or Gendicine ® ) in treatment of multiple lung metastases tumor from Hepatocellular Carcinoma (HCC). Methods: Thirty two patients with HCC and multiple pulmonary metastases were included in this study. Lung metastatic tumors were treated using bronchial arterial infusion of rAd-p53 via a transcatheter. Two infusions, once per week, were given to each lung area containing metastatic tumors at a dose of 2-4 × 10 12 Virus Particles (VP) per infusion. All these patients were followed up every 3 month. Spiral CT was performed during follow-up visits to monitor tumor progress. Results: At 3 months after the last treatment, 6 patients showed lung metastatic tumors completely disappeared, 15 patients showed a decrease in number of tumors, 2 patients un-changed in tumor number, and 9 patients developed new metastatic tumors. Overall survival rate of one year was 93.7% and median survival time was 18.4 months. There were no serious adverse events except for self-limited fever (38° C-39.5° C) was found in 28 patients. Conclusions: Bronchial arterial infusion of rAd-p53 is an effective and safe in treatment of multiple lung metastatic tumors of HCC.