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. |
ClinicalTrials.gov 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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: Surgery combined with rAd-p53 gene therapy Procedure: Surgery | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | August 2012 |
Estimated Primary Completion Date : | August 2015 |
Estimated Study Completion Date : | October 2015 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- local recurrent rate [ Time Frame: 3 years ]
- quality of life [ Time Frame: 3 years ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574729
Contact: Qunyou Tan, M.D., Ph.D | 13983770929 | 13983770929@163.com |
China, Chongqing | |
Institute of Surgery Research, Daping Hospital, Third Military Medical University | |
Chongqing, Chongqing, China, 40042 | |
Contact: Qunyou Tang, M.D., Ph.D 13983770929 13983770929@163.com | |
Principal Investigator: qunyou tan, M.D., Ph.D |
Principal Investigator: | Qunyou Tan, M.D., Ph.D | Institute of Surgery Research, Daping Hospital, Third Military Medical University |
Responsible Party: | Shenzhen SiBiono GeneTech Co.,Ltd |
ClinicalTrials.gov Identifier: | NCT01574729 |
Other Study ID Numbers: |
rAd-p53NSCLC |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | June 28, 2012 |
Last Verified: | June 2012 |
p53 gene therapy non-small cell lung cancer post-surgery chemotherapy |
Carcinoma, Non-Small-Cell Lung Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |