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Background: Combined p53 gene therapy (rAd-p53) and intra-arterial delivery of chemotherapeutic agents for treatment of oral squamous cell carcinoma were evaluated.Methods: Ninety nine patients with stage Ⅲ or Ⅳ oral carcinoma who had refused or were ineligible for surgery were enrolled in a phase Ⅱ placebo controlled, double blind, randomized phase Ⅱ clinical trial.They were randomly assigned to Group Ⅰ (n=35; intra-arterial infusion of rAd-p53 plus chemotherapy), Group Ⅱ (n=33; intra-arterial infusion ofrAd-p53 plus placebo chemotherapy), or Group Ⅲ (n=31; intra-arterial infusion of placebo rAd-p53 plus chemotherapy).