Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The role of maintenance therapy in the management of Small Cell Lung Cancer (SCLC) has not been confirmed. Many treatment modalities like chemotherapy, interferons and other biological agents have been tested as maintenance therapy in SCLC, but the results are disappointing. A marginal survival advantage is seen in maintenance with chemotherapy and interferon-alpha, however, the functioning status and immune system may get worse, which subsequently has a negative impact on patient's quality-of-life. Immunotherapy with autologous cytokine-induced killer (CIK) cells can activate the antitumor defense mechanism through stimulating immune response and altering the interaction between tumor and its host. This effect may result in improved tumor control and survival, as well as a better quality of life. To test the hypothesis, a randomized controlled study was conducted to compare CIK cells with best supportive care as maintenance therapy for SCLC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven small cell lung cancer
- •Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a platinum-based drug as first-line therapy in the absence of disease progression
- •Age between 18-75
- •Performance status ≤2
- •No uncontrolled metabolic disease, infection, and neurological disorders
- •No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart disease
- •Life expectancy more than three months.
- •Without contraindication of immunotherapy with autologous cytokine-induced killer cells
- •No other malignancies
- •Signed study-specific consent form prior to study entry
排除标准
- •Patients receiving other anti-tumor therapy (like thermotherapy)
- •Pregnant or lactating women
- •Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced killer cells
- •Uncontrolled mental disorder
- •Patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases
结局指标
主要结局
Progression-free survival
时间窗: One year
次要结局
- Overall survival(Two years)
- Quality-of-life(2 years)
研究者
Guosheng Feng
Professor
People's Hospital of Guangxi