Abstract

Purpose: Advances in tumor biology and clinical trials indicate that p53 transfer is an alternative therapy for head and neck squamous cell carcinoma. The current inquiry was a single-center, phase I study of the rAd-p53 repeated intraepithelial injection for dysplastic oral leukoplakia (OLK), the most common precursor of the oral squamous cell carcinoma. The primary objective was to determine the feasibility and safety of this therapy, while the secondary objective was to observe biological responses and preliminary curative effects.

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