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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: Surgery; Drug: 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

Study Timeline

• Study First Submitted: 2012-04-06
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-27
• Last Update Posted: 2012-06-28
• Study Start: 2012-08
• Primary Completion: 2015-08
• Study Completion: 2015-10

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