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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd Identifier:
First received: April 6, 2012
Last updated: June 27, 2012
Last verified: June 2012

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.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Surgery combined with rAd-p53 gene therapy
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Shenzhen SiBiono GeneTech Co.,Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • local recurrent rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgery plus post-surgery chemotherapy
Surgery plus post-surgery chemotherapy
Procedure: Surgery
Surgery plus post-surgery chemotherapy
Experimental: Surgery combined with rAd-p53 gene therapy
Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy
Drug: Surgery combined with rAd-p53 gene therapy
Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01574729

Contact: Qunyou Tan, M.D., Ph.D 13983770929

China, Chongqing
Institute of Surgery Research, Daping Hospital, Third Military Medical University Not yet recruiting
Chongqing, Chongqing, China, 40042
Contact: Qunyou Tang, M.D., Ph.D    13983770929   
Principal Investigator: qunyou tan, M.D., Ph.D         
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
Principal Investigator: Qunyou Tan, M.D., Ph.D Institute of Surgery Research, Daping Hospital, Third Military Medical University
  More Information

Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd Identifier: NCT01574729     History of Changes
Other Study ID Numbers: rAd-p53NSCLC 
Study First Received: April 6, 2012
Last Updated: June 27, 2012
Health Authority: China: Military Health Department

Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53 gene therapy
non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms processed this record on May 26, 2016