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E10A for the Treatment of Squamous Cell Carcinoma of the Head and Neck

NCT02630264 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2015-12-15

No results posted yet for this study

Summary

Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug. E10A contains a recombinant human endostatin gene with the second-generation recombinant adenovirus as its vector. After transfection tumor cells. E10A expresses human endostatin, which inhibits vascular endothelial cell proliferation and tumor angiogenesis, and blocks tumor blood supply, thereby specifically inhibiting tumor growth and inducing apoposis of tumor cells. Both pre-clinical and animal models have demonstrated the anti-tumor activities of E10A. The safety and efficacy of E10A in treating head and neck cancer has also been demonstrated in Phase I and Phase II studies.

Conditions

  • Head and Neck Neoplasms

Interventions

DRUG

Endostatins

Specification: 1mL/division, 1×1012 VP/1.0mL E10A preparation: 1. Thaw frozen E10A stored at -20°C vials at room temperature until E10A is liquid. 2. Swirl gently. Do NOT shake. Method of administration 1. E10A was diluted with 0.9% sodium chloride to appropriate dose according to the longest diameter of the target lesion. 2. After local anesthesia, we penetrated the syringe under normal skin subcutaneously 5 mm into the tumor or vertically into the lymph node under direct visualization and withdrew it to confirm the absence of blood. 3. Applied local compression for 10 minutes and pasted a sterile sticker on the injection site to avoid bleeding.

DRUG

Paclitaxel injection

Specification: 30mg/5mL, Usage: 160mg/m2 on day 3, according to instruction.

DRUG

Cisplatin injection

Specification: 20mg Usage: Cisplatin 25mg/ m2 on day 3, 4, and 5,according to instruction.

Sponsors & Collaborators

  • Guangzhou Double Bioproducts Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huiqiang Huang, Ph.D · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-06-30
Completion
2016-12-31

Countries

  • China

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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 NCT02630264 on ClinicalTrials.gov