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

June 27, 2012 updated by: Shenzhen SiBiono GeneTech Co.,Ltd

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 40042
        • Institute of Surgery Research, Daping Hospital, Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 year after the treatment
determine the 3-years overall survival
3 year after the treatment
adverse effects
Time Frame: from starting treatment to 30 days after treatment
from starting treatment to 30 days after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life
Time Frame: 3 years
3 years
local recurrent rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

Investigators

  • Principal Investigator: Qunyou Tan, M.D., Ph.D, Institute of Surgery Research, Daping Hospital, Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

April 6, 2012

First Submitted That Met QC Criteria

April 6, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rAd-p53NSCLC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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