A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.
详细描述
About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with staging Ⅱ-Ⅲ of NPC;
- •Patients who had completed concurrent of radiotherapy and chemotherapy;
- •Patients who have a life expectancy of at least 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
- •The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
- •The ECG results were normal, and the liver and kidney were functional.
排除标准
- •Patients who had distant metastases by imaging studies;
- •Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- •Patients who were pregnant or lactating;
- •ECOG perform status ≥ 2;
- •Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
结局指标
主要结局
progression-free survival(PFS)
时间窗: 1 month
次要结局
- overall survival(OS)(1 month)
研究者
Weiliang Sun
investigator
Guangxi Medical University