一项评估α-半乳糖神经酰胺脉冲树突状细胞辅助免疫疗法对完全切除的II-IIIA期非小细胞肺癌患者疗效的随机II期研究：一项随机对照试验的研究方案
A randomized phase II study to assess the effect of adjuvant immunotherapy using α-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer: study protocol for a randomized controlled trial.
作者信息
Saka Hideo, Kitagawa Chiyoe, Ichinose Yukito, Takenoyama Mitsuhiro, Ibata Hidenori, Kato Tatsuo, Takami Koji, Yamashita Motohiro, Maeda Tadashi, Takeo Sadanori, Ueda Hitoshi, Okabayashi Kan, Nagashima Seiji, Oka Tadayuki, Kouso Hidenori, Fukuyama Seiichi, Yoshimoto Kentaro, Shimokawa Mototsugu, Saito Akiko M, Ito Suminobu
机构信息
Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Clinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
出版信息
Trials. 2017 Sep 15;18(1):429. doi: 10.1186/s13063-017-2103-4.
BACKGROUND
As the toxicity associated with the α-GalCer-pulsed dendritic cell (DC) therapy could be considered to be negligible, its addition to postoperative adjuvant chemotherapy would be expected to greatly improve the therapeutic effect, and could result in prolonged survival. The aim of the present study is to compare the therapeutic efficacy of alpha-galactosylceramide-pulsed DC therapy in patients who have undergone a complete resection of stage II-IIIA non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant therapy with cisplatin plus vinorelbine, to that in patients who did not receive additional treatment (surgical resection plus postoperative adjuvant chemotherapy only).
METHODS
Subsequent to the complete resection of NSCLC, followed by the administration of cisplatin plus vinorelbine dual-agent combination adjuvant chemotherapy, patients who satisfy the inclusion criteria will be randomly allocated to either the α-GalCer-pulsed DC immune therapy group, or the standard treatment group. In total, 56 patients will be included in the study. The primary endpoint is recurrence-free survival, and the secondary endpoints are natural killer T-cell-specific immune response, the frequency of toxic effects and safety, and overall survival.
DISCUSSION
In order to determine the efficacy of α-GalCer-pulsed DC therapy, the present study compares patients with stage II-III NSCLC who underwent complete surgical resection followed by postoperative adjuvant therapy with cisplatin plus vinorelbine, to those who did not receive additional treatment (surgical resection plus postoperative adjuvant chemotherapy only).
TRIAL REGISTRATION
UMIN000010386 ( R000012145 ). Registered on 1 April 2013. UMIN-CTR is officially recognized as a registration site which satisfies ICMJE criteria.
背景
鉴于与α-半乳糖神经酰胺脉冲树突状细胞（DC）疗法相关的毒性可被认为微不足道，将其添加到术后辅助化疗中有望显著提高治疗效果，并可能延长生存期。本研究的目的是比较接受了II-IIIA期非小细胞肺癌（NSCLC）完全切除并随后接受顺铂加长春瑞滨术后辅助治疗的患者，与未接受额外治疗（仅手术切除加术后辅助化疗）的患者，接受α-半乳糖神经酰胺脉冲DC疗法的治疗效果。
方法
在NSCLC完全切除后，给予顺铂加长春瑞滨双药联合辅助化疗，符合纳入标准的患者将被随机分配到α-半乳糖神经酰胺脉冲DC免疫治疗组或标准治疗组。本研究共纳入56例患者。主要终点是无复发生存期，次要终点是自然杀伤T细胞特异性免疫反应、毒性作用频率和安全性以及总生存期。
讨论
为了确定α-半乳糖神经酰胺脉冲DC疗法的疗效，本研究将接受了完全手术切除并随后接受顺铂加长春瑞滨术后辅助治疗的II-III期NSCLC患者，与未接受额外治疗（仅手术切除加术后辅助化疗）的患者进行比较。
试验注册
UMIN000010386（R000012145）。于2013年4月1日注册。UMIN-CTR被正式认可为符合ICMJE标准的注册网站。
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