drugset / Trial / NCT01574729

Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma

NCT01574729 ↗

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

Summary

The primary objectives of this study are to investigate the efficacy and safety of surgery combined with rAd-p53 gene therapy in treatment of advanced Non-small-cell lung carcinoma (NSCLC). The study efficacy endpoints include overall survival, progress-free survival, quality of life, and local recurrent rate. The safety endpoint is complications and adverse effects. The study hypothesis: rAd-p53 gene therapy can prolong the overall survival and reduce the local recurrent rate.

Timeline

Start
2012-08
Primary completion
2015-08
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject rAd-p53 Unknown — —