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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.
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
- 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
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