Adjuvant immunotherapy with autologous dendritic cells for hepatocellular carcinoma, randomized phase II study.

ABSTRACT: Our previous phase I/IIA study showed that autologous dendritic cells (DCs) pulsed with tumor-associated antigens are well tolerated in patients with hepatocellular carcinoma (HCC). In this randomized, multicenter, open-label, phase II trial, we investigated the efficacy and safety of this DC-based adjuvant immunotherapy with 156 patients, who treated for HCC with no evidence of residual tumor after standard treatment modalities. Patients were randomly assigned to immunotherapy (n = 77; injection of 3 × 10⁷ DC cells, six times over 14 weeks) or control (n = 79; no treatment). The primary end point was recurrence-free survival (RFS), and the secondary endpoints were immune response and safety. The RFS between the immunotherapy and control groups was not significantl

SUBMITTER: Lee JH 

PROVIDER: S-EPMC5543846 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature