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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Surgery combined with rAd-p53 gene therapy
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery plus post-surgery chemotherapy<br>Surgery plus post-surgery chemotherapy | Procedure: Surgery<br>* Surgery plus post-surgery chemotherapy<br>|
| Experimental: Surgery combined with rAd-p53 gene therapy<br>Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy | Drug: Surgery combined with rAd-p53 gene therapy<br>* Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | determine the 3-years overall survival | 3 year after the treatment | 
| adverse effects |  | from starting treatment to 30 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrent rate |  | 3 years | 
| quality of life |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy