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rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors

NCT00902083 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2012-04-09

No results posted yet for this study

Summary

This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

Conditions

  • Advanced Oral and Maxillofacial Malignant Tumors

Interventions

DRUG

p53 gene with surgery

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

PROCEDURE

surgery

remove tumor surgery

DRUG

p53 with chemotherapy

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy

DRUG

p53 gene therapy

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

Sponsors & Collaborators

  • Shenzhen SiBiono GeneTech Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Longjiang Li, PhD, MD · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • China

Study Locations

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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 NCT00902083 on ClinicalTrials.gov