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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
Surgery plus post-surgery chemotherapy
Institute of Surgery Research, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
overall survival
determine the 3-years overall survival
Time frame: 3 year after the treatment
adverse effects
Time frame: from starting treatment to 30 days after treatment
local recurrent rate
Time frame: 3 years
quality of life
Time frame: 3 years
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