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

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Surgery combined with rAd-p53 gene therapy

Surgery

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institute of Surgery Research, Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery plus post-surgery chemotherapy

Surgery combined with rAd-p53 gene therapy

Arm Description

Surgery plus post-surgery chemotherapy

Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy

Outcomes

Primary Outcome Measures

overall survival

determine the 3-years overall survival

adverse effects

Secondary Outcome Measures

local recurrent rate

quality of life

Full Information

NCT ID

NCT01574729

First Posted

April 6, 2012

Last Updated

June 27, 2012

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01574729

Brief Title

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

Acronym

rAd-p53

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

p53 gene therapy, non-small cell lung cancer, post-surgery, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery plus post-surgery chemotherapy

Arm Type

Active Comparator

Arm Description

Surgery plus post-surgery chemotherapy

Arm Title

Surgery combined with rAd-p53 gene therapy

Arm Type

Experimental

Arm Description

Surgery combined with the surgery wound surface injection of rAd-p53 plus post-surgery chemotherapy

Intervention Type

Drug

Intervention Name(s)

Surgery combined with rAd-p53 gene therapy

Intervention Description

Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Surgery plus post-surgery chemotherapy

Primary Outcome Measure Information:

Title

overall survival

Description

determine the 3-years overall survival

Time Frame

3 year after the treatment

Title

adverse effects

Time Frame

from starting treatment to 30 days after treatment

Secondary Outcome Measure Information:

Title

local recurrent rate

Time Frame

3 years

Title

quality of life

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qunyou Tan, M.D., Ph.D

Phone

13983770929

13983770929@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qunyou Tan, M.D., Ph.D

Organizational Affiliation

Institute of Surgery Research, Daping Hospital, Third Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Surgery Research, Daping Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

40042

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qunyou Tang, M.D., Ph.D

Phone

13983770929

13983770929@163.com

First Name & Middle Initial & Last Name & Degree

qunyou tan, M.D., Ph.D

12. IPD Sharing Statement

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

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