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

This study is not yet open for participant recruitment.
Verified June 2012 by Shenzhen SiBiono GeneTech Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01574729
First received: April 6, 2012
Last updated: June 27, 2012
Last verified: June 2012

April 6, 2012
June 27, 2012
August 2012
August 2015   (final data collection date for primary outcome measure)
  • overall survival [ Time Frame: 3 year after the treatment ] [ Designated as safety issue: No ]
    determine the 3-years overall survival
  • adverse effects [ Time Frame: from starting treatment to 30 days after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01574729 on ClinicalTrials.gov Archive Site
  • local recurrent rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
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
Both
18 Years and older
No
Contact: Qunyou Tan, M.D., Ph.D 13983770929 13983770929@163.com
China
 
NCT01574729
rAd-p53NSCLC
No
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