Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Surgery combined with rAd-p53 gene therapy Type: Drug
Name: Surgery Type: Procedure
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- historically diagnosed advanced non-small lung cancer

- has surgery indication

- age 18 years old or greater

- life expectancy greater than 12 weeks

- ECOG: 0-2

- no prior chemotherapy, radiotherapy in 2 weeks

- Neutrophils≥1.5×10^9/L,platelet≥80×10^9/L, Hb≥≥80g/L,bilirubin≤1.5×2mg/dl, ALT and AST≤2×institutional upper limit of normal,Cr≤1.5×institutional upper limit of normal,coagulation tests(INR and PTT)within normal range

- subject provides signed informed consent

Exclusion Criteria:

- hypersensitive to study drug

- with a coagulational test unnormal or a bleeding disorder

- infections

- with serious condition which can't stand a surgery

- pregnant or lactating

- principle investigator consider not suitable
Location
Institute of Surgery Research, Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China
Status: Not yet recruiting
Contact: Qunyou Tang, M.D., Ph.D - 13983770929 - 13983770929@163.com
Start Date
August 2012
Completion Date
October 2015
Sponsors
Shenzhen SiBiono GeneTech Co.,Ltd
Source
Shenzhen SiBiono GeneTech Co.,Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page