J Cancer 2017; 8(10):1826-1832. doi:10.7150/jca.18946

Research Paper

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

Kecheng Zhang1*, Zheng Peng1*, Xiaohui Huang1*, Zhi Qiao1*, Xinxin Wang1, Ning Wang1, Hongqing Xi1, Jianxin Cui1, Yunhe Gao1, Xijian Huang2, Hua Gao2, Bo Wei1✉, Lin Chen1✉

1. Department of General Surgery & Institute of General Surgery, Chinese People's Liberation Army General Hospital, Fuxing Road 28, Beijing 100853, China
2. Cure&Sure Biotech Co., LTD, Hi-tech Industrial Park, Shenzhen 518057, P.R. China
*These authors contributed equally to this work.

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) license (https://creativecommons.org/licenses/by-nc/4.0/). See http://ivyspring.com/terms for full terms and conditions.
Zhang K, Peng Z, Huang X, Qiao Z, Wang X, Wang N, Xi H, Cui J, Gao Y, Huang X, Gao H, Wei B, Chen L. Phase II Trial of Adjuvant Immunotherapy with Autologous Tumor-derived Gp96 Vaccination in Patients with Gastric Cancer. J Cancer 2017; 8(10):1826-1832. doi:10.7150/jca.18946. Available from http://www.jcancer.org/v08p1826.htm

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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.

Keywords: gp96 vaccines, immunotherapy, gastric cancer, phase II study