NCT01574729

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

Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Surgery combined with rAd-p53 gene therapy	Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
PROCEDURE	Surgery	Surgery plus post-surgery chemotherapy

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-08-01
• Completion: 2015-10-01
• First posted: 2012-04-10
• Last updated: 2012-06-28

Locations

1 site across 1 country: China