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

NCT01574729 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-06-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Shenzhen SiBiono GeneTech Co.,Ltd

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574729 on ClinicalTrials.gov