Clinical Trial: Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma
Brief 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.
Detailed Summary:
Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd
Current Primary Outcome:
- overall survival [ Time Frame: 3 year after the treatment ]determine the 3-years overall survival
- adverse effects [ Time Frame: from starting treatment to 30 days after treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- local recurrent rate [ Time Frame: 3 years ]
- quality of life [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Shenzhen SiBiono GeneTech Co.,Ltd
Dates:
Date Received: April 6, 2012
Date Started: August 2012
Date Completion: October 2015
Last Updated: June 27, 2012
Last Verified: June 2012
