目的：探讨自体DC-CIK细胞联合化疗治疗局部晚期不可切除或转移性胃腺癌的临床疗效和安全性。 方法 ：收集2014年11月至2016年7月就诊于中国医学科学院肿瘤医院的32例晚期胃腺癌患者，按照随机对照表法以1∶1分为DC-CIK细胞联合用药组与单药组（每组各16例），两组患者基线资料均衡一致。分别采集PBMC，经实验室体外诱导培养获得DC和CIK细胞。单药组采用替吉奥/奥沙利铂或顺铂化疗方案，联合用药组采用相同化疗方案+DC-CIK细胞治疗。分析比较两组患者治疗前后外周血T淋巴细胞亚群、临床治疗效果、不良反应发生情况和生活质量改善情况。 结果： 联合用药组患者治疗前后外周血T细胞亚群无明显变化（P>0.05），单药组患者化疗后外周血中CD3 + 、CD3 + CD4 + 、CD3 + CD8 + 、CD3 - CD56 + 细胞百分比明显低于治疗前（均P<0.05）。联合用药组患者疾病控制率、无进展生存期均高于单药组（87.5% vs 50.0%，8.9 vs 4.4个月；均P<0.05），两组中位生存期分别为18.0和14.0个月（P>0.05）。联合用药组治疗后明显改善了患者因化疗毒副反应或病情本身引起的体力匮乏和失眠，未见治疗相关严重不良反应。 结论： DC-CIK细胞联合化疗可明显改善局部晚期不可切除转移性胃腺癌患者免疫状态和生活质量，提高了临床疗效，无明显不良反应。

Objective: To investigate the clinical efficacy and safety of autogenous dendritic cell-cytokine induced killer (DC-CIK) cell combined with chemotherapy in treatment of locally advanced unresectable or metastatic gas-tric adenocarcinoma. Methods: In this randomized and controlled trial, 32 patients with advanced gastric adenocar-cinoma, who were hospitalized in the Department of Medical Oncology, Cancer Hospital, Chinese Academy of Med-ical Sciences during November, 2014 to July, 2016, were divided into the combined treatment group (16 cases for DC-CIK cell combined chemotherapy) and the mono-drug group (16 cases for chemotherapy alone) by the ration of 1∶1. The baseline data of two groups were comparable. Peripheral blood mononuclear cells (PBMCs) were collected from patients of both groups to obtain DC and CIK cells via in vitro culture. The mono-drug group was treated with SOX or SP chemotherapy regimen, while combined treatment group was treated with referred chemotherapy com-bined with DC-CIK cells. The adverse reactions, curative effect, peripheral blood T cell subsets and qualities of life of the patients in two groups were compared and analyzed. Results: There was no significant difference in T cell subsets in the combined treatment group compared with pre-treatment value (P>0.05); However, the post-treatment percentage of CD3 + , CD3 + CD4 + , CD3 + CD8 + and CD3 - CD56 + in peripheral blood decreased significantly in the mono-drug group(P<0.05). The disease control rate and progression free survival in combined treatment group were signif-icantly increased compared to the mono-drug group (87.5% vs 50%，8.9 months vs 4.4 months, respectively, all P<0.05). There was no significant difference in overall survival between two groups (18.0 months vs 14.0 months, P>0.05). After treatment, compared with the mono-drug group, fatigue and insomnia caused by chemotherapy or dis-ease itself in the combined treatment group was significantly improved (P<0.05). No severe toxicity was observed after infusion of DC-CIK cells. Conclusion: The treatment of DC-CIK cells combined with chemotherapy can obvi-ously optimize the immune function and improve the life quality of the patients with locally advanced unresectable or metastatic gastric adenocarcinoma; the combined treatment improved clinical efficacy and did not bring any obvi-ous adverse reactions.

北京市科技计划项目资助（No. Z14010101101）