drugset / Trial / NCT02630264

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

NCT02630264 ↗

Phase 3 Unknown 540 enrolled Guangzhou Double Bioproducts Co., Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-06
Primary completion
2016-06
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 25 mg/m2 —
Subject Endostatins Protein / enzyme biologic 1e+12 unknown Other
Subject Paclitaxel Small molecule 160 mg/m2 —