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Recombinant Human Endostatin Adenovirus Combined With Chemotherapy for Advanced Head and Neck Malignant Tumors

NCT02283489 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2014-11-05

No results posted yet for this study

Summary

This study will investigate the efficacy and safety of recombinant human endostatin adenovirus combined with chemotherapy for advanced head and neck malignant tumors.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

recombinant human endostatin adenovirus

Specification: 1mL/division, 1.0×1012 virus particle (VP). ESD01 preparation: Thaw at room temperature, dilute with normal saline to required volume (no more than 2 mL). Method of administration: Intratumor injection, once a week for 2 weeks, every 3 weeks for one cycle. Select only one target lesion even when lesions are present. The target lesion is the largest and easiest to inject. This will be fixed during the study.

DRUG

Cisplatin injection

Specification: 2ml: 10mg. Usage: 25mg/m2, days 1 to 3, according to instruction.

DRUG

Paclitaxel injection

Specification: 5ml: 30mg. Usage: 160mg/m2 intravenously on day 1, according to instruction.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Renmiao Zhang

    lead INDUSTRY

Principal Investigators

  • Renmiao Zhang, MD, PhD · Chengdu Shi Endor Biological Engineering Technology Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-10-31
Completion
2016-10-31

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 NCT02283489 on ClinicalTrials.gov