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

Non-small Cell Lung Cancer Clinical Trial

— rAd-p53  

Official title:

Phase II Study of Surgery Combined With Recombinant Adenoviral Human p53 Gene Therapy in Treatment Advanced Non-small-cell Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01574729
• Other study ID #: rAd-p53NSCLC
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 6, 2012
• Last updated: June 27, 2012
• Start date: August 2012
• Est. completion date: October 2015

Study information

• Verified date: June 2012
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Qunyou Tan, M.D., Ph.D
• Phone: 13983770929
• Email: 13983770929[@]163.com
• Is FDA regulated: No
• Health authority: China: Military Health Department
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Institute of Surgery Research, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	determine the 3-years overall survival	3 year after the treatment	No
Primary	adverse effects		from starting treatment to 30 days after treatment	Yes
Secondary	local recurrent rate		3 years	No
Secondary	quality of life		3 years	No