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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01574729
Recruitment Status : Unknown
Verified June 2012 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2012
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd

April 6, 2012
April 10, 2012
June 28, 2012
August 2012
August 2015   (Final data collection date for primary outcome measure)
  • overall survival [ Time Frame: 3 year after the treatment ]
    determine the 3-years overall survival
  • adverse effects [ Time Frame: from starting treatment to 30 days after treatment ]
Same as current
Complete list of historical versions of study NCT01574729 on Archive Site
  • local recurrent rate [ Time Frame: 3 years ]
  • quality of life [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma
Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • Drug: Surgery combined with rAd-p53 gene therapy
    Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
  • Procedure: Surgery
    Surgery plus post-surgery chemotherapy
  • Active Comparator: Surgery plus post-surgery chemotherapy
    Surgery plus post-surgery chemotherapy
    Intervention: Procedure: Surgery
  • Experimental: Surgery combined with rAd-p53 gene therapy
    Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
    Intervention: Drug: Surgery combined with rAd-p53 gene therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Shenzhen SiBiono GeneTech Co.,Ltd
Shenzhen SiBiono GeneTech Co.,Ltd
Not Provided
Principal Investigator: Qunyou Tan, M.D., Ph.D Institute of Surgery Research, Daping Hospital, Third Military Medical University
Shenzhen SiBiono GeneTech Co.,Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP