Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Phase 2
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Procedure: SurgeryDrug: Surgery combined with rAd-p53 gene therapy
- Registration Number
- NCT01574729
- Lead Sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery plus post-surgery chemotherapy Surgery Surgery plus post-surgery chemotherapy Surgery combined with rAd-p53 gene therapy Surgery combined with rAd-p53 gene therapy Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
- Primary Outcome Measures
Name Time Method overall survival 3 year after the treatment determine the 3-years overall survival
adverse effects from starting treatment to 30 days after treatment
- Secondary Outcome Measures
Name Time Method local recurrent rate 3 years quality of life 3 years
Trial Locations
- Locations (1)
Institute of Surgery Research, Daping Hospital, Third Military Medical University
🇨🇳Chongqing, Chongqing, China