Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study.~Primary objectives: Safety Immunological efficacy, expressed as number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of Colon-Rectal Cancer (CRC)-associated antigens.~Secondary objectives: Clinical outcome of the patients (OS, RFS, TTR). To evaluate the predictive role of the development of a positive DTH test after at least three vaccine administrations.~To evaluate the persistence of an antitumor immune response after the completion of the vaccination program.~To evaluate the prognostic or predictive role of the enhancement of a specific immune response.~To evaluate a panel of inflammatory cytokines involved in antitumor immune response.~To evaluate the predictive role of immune cells in tumour microenvironment. To evaluate the predictive role of tumour antigen expression.~This is a two-stage, phase 2 clinical trial designed according to Simon minimax design. A 40% immune response rate would preclude further studies, while a 70% immune response rate would indicate that further studies would be warranted. Given α and β error of 0.1, the first stage will require enrolment of 7 patients. If at least 3 patients show an immune response and toxicity is acceptable, the study will proceed to the second stage and additional 12 patients will be enrolled.~The vaccine will be considered immunologically active if at least 11 patients are immunological responders.
Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer