A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
- 主要终点
- progression-free survival(PFS)
研究概览
简要总结
Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder Cancer.
详细描述
About 1500 patients with staging I-III of Bladder Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients histologically confirmed carcinoma in of the bladder with urinary cytology;
- •Patients with staging I-III of Bladder Cancer;
- •Patients who had completed 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>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L);
- •The ECG results were normal, and the liver and kidney were functional.
排除标准
- •Patients who had upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risk;
- •Patients who had urethral strictures that would prevent endoscopic procedures and repeated catheterization;
- •Patients who had prior or concurrent upper urinary tract tumors;
- •Patients who had distant metastases by imaging studies;
- •Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- •Patients who were lactating;
- •ECOG perform status ≥ 2;
- •Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
- •Patients who are pregnant or nursing;
- •Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
- •Patients with disease that would preclude general anesthesia;
- •Patients with active intractable or uncontrollable infection.
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)