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

• Status: Unknown status
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

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