To hear about similar clinical trials, please enter your email below
Trial Title:
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
NCT ID:
NCT01574729
Condition:
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
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surgery combined with rAd-p53 gene therapy
Description:
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
Arm group label:
Surgery combined with rAd-p53 gene therapy
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Surgery plus post-surgery chemotherapy
Arm group label:
Surgery plus post-surgery chemotherapy
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Surgery Research, Daping Hospital, Third Military Medical University
Address:
City:
Chongqing
Zip:
40042
Country:
China
Contact:
Last name:
Qunyou Tang, M.D., Ph.D
Phone:
13983770929
Email:
13983770929@163.com
Investigator:
Last name:
qunyou tan, M.D., Ph.D
Email:
Principal Investigator
Start date:
August 2012
Completion date:
October 2015
Lead sponsor:
Agency:
Shenzhen SiBiono GeneTech Co.,Ltd
Agency class:
Industry
Source:
Shenzhen SiBiono GeneTech Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01574729
