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

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.

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