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p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage

NCT00894153 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

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 , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .

Conditions

  • Neoplasms

Interventions

DRUG

chemotherapy plus p53

chemotherapy plus p53

DRUG

chemotherapy

chemotherapy

RADIATION

radiotherapy

radiotherapy

Sponsors & Collaborators

  • Shenzhen SiBiono GeneTech Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT00894153 on ClinicalTrials.gov