Objective　To evaluate the efficacy of Rb gene therapy in head and neck carcinoma. Methods　We investigated the adenovirus-mediated Rb (Ad-Rb) gene transfect into human oral squamous cell carcinoma cell line (012) in both in vitro and in vivo models. Results　The cells growth curve for 012 tumor cells transfect with Ad-Rb became lower after two days transfection and declined slightly by six days. Tumor growth in nude mice was also significantly retarded following Ad-Rb injection when compared with controls. Ad-Rb expression was identified by Western blotting in those tumors injected with Ad-Rb. Conclusion　These results implicated that the recombinant Rb gene adenovirus vector could efficiently transfect and inhibit oral squmous cell carcinoma. It might be an important candidate for gene therapy in head and neck cancer.