Phase II Trial of Adjuvant Immunotherapy with Autologous Tumor-derived Gp96 Vaccination in Patients with Gastric Cancer.

Background/Aims: Autologous, tumor-derived, heat shock protein gp96 peptide complexes have antitumor potential. We conducted the first Phase II trial to evaluate the safety and efficacy of gp96 vaccination in adjuvant settings for patients with gastric cancer. Methods: We enrolled 73 consecutive patients from October 2012 to December 2015. Thirty-eight patients received gp96 vaccination plus chemotherapy and 35 received chemotherapy alone. The primary endpoints were disease-free survival (DFS) and toxicity. The secondary endpoints were overall survival (OS) and tumor-specific immune responses. Results: There were comparable baseline characteristics between the two groups. Tumor-specific immune responses increased significantly after gp96 vaccination. gp96 vaccination plus chemotherapy was well tolerated and there were no gp96-related serious adverse events. Patients who received gp96 vaccination had improved DFS compared with those who did not [p = 0.045; hazard ratio (HR): 0.47; 95% confidence interval (CI): 0.23-0.96]. The 2-year OS rates were 81.9% and 67.9% for the gp96 vaccination and chemotherapy alone group, respectively (p = 0.123; HR: 0.42; 95% CI: 0.15-1.24). Conclusion: gp96 vaccination elicits tumor-specific immune responses and can be safely used in adjuvant settings combined with chemotherapy. Patients with less-aggressive diseases might benefit from gp96 therapy.