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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

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