Autologous Formalin-Fixed Tumor Vaccine

T.      Ohno

Abstract

A novel tumor vaccine consisting of autologous formalin-fixed tumor fragments, cytokine-encapsulated microparticles, and an adjuvant was developed. Although mice experiments revealed mild efficacy, vaccination in a Phase I/IIa clinical trial of patients after resection of hepatocellular carcinoma resulted in significantly longer time before the first recurrence with no problematic adverse effect, than compared to historical control patients operated in the same department. In the followed academic Phase IIb randomized clinical trial, the vaccination significantly improved the recurrence-free survival and overall survival rates in a median follow-up of 15 months. The vaccine will be promising against recurrence of many types of human cancers after resection.

Keywords: cancer, cytokine, cytotoxic t lymphocyte, hepatocellular carcinoma, immunotherapy, overall survival, randomized clinical trial, tumor vaccine