Autologous Cytokine-induced Killer Cells Combined Chemotherapy in Advanced Pancreatic Cancer: A Prospective, Randomized, Open, Single Center Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine whether Cytokine induced killer cells combined chemotherapy is more effective in the treatment of advanced Pancreatic Cancer.
详细描述
Pancreatic cancer is a devastating malignant disease with a median survival of 3-6 months and a 5-year survival rate of less than 5%. It is necessary to explore more treatment mode to pancreatic cancer especially advanced stage patients. This study is a prospective, randomized, open, single center phase II study. The investigators try to evaluate the efficacy and safety of this treatment mode.
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
- •No less than 18 years old
- •Karnofsky Performance Status over 60
- •Life expectancy more than three months
- •Pathological diagnosed as pancreatic epithelial cell carcinoma
- •Recurrence after surgery or unresectable
- •No experienced chemotherapy or the interval between the last adjuvant chemotherapy and relapse is at least 6 months
- •Measurable lesions (by CT or MRI)
- •No serious mental disorders
- •Adequate organ and bone marrow functions
- •No other serious and the conflict diseases(such as autoimmune diseases, immunodeficiency, organ transplantation)
- •No other malignant tumor history
- •Informed consent and willing to participate in this study
排除标准
- •Received immunosuppressants or glucocorticoid treatment
- •Uncontrolled severe infection or unhealed wound caused by suppurative inflammation
- •Heart disease, insufficient heart function, II degree heart block or occurred myocardial infarction in 6 months
- •Poor pulmonary functions caused by interstitial lung disease and pulmonary reserve volume under 80% of the expected value
- •Other malignant tumor history
- •Transaminase>2.5ULN or bilirubin>3ULN or creatinine >1.25ULN
- •Pregnant or lactating women
- •Obvious bleeding tendency
- •Participated other clinical trails in 1 month
- •Other unsuitable conditions: HIV infection, intravenous drug abusers, etc
研究组 & 干预措施
Chemotherapy
Tegafur,Gimeracil and Oteracil Potassium Capsules 40-60mg, bid, po, D1-14, Q3w
干预措施: Tegafur-Gimeracil-Oteracil Potassium (Drug)
CIK combined chemotherapy
Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.
干预措施: Cytokine-induced Killer Cells (Biological)
CIK combined chemotherapy
Autologous Cytokine induced killer cells combined Tegafur, Gimeracil and Oteracil Potassium Capsules. After 2 to 4 days of chemotherapy, about 5×10９autologous cytokine induced killer cells are transfused into the vein of the patients in one hour.
干预措施: Tegafur-Gimeracil-Oteracil Potassium (Drug)
结局指标
主要结局
Overall Survival
时间窗: From the date of randomization to the date of death from any cause up to 36 months
次要结局
- Progression Free Survival(From the date of randomization to the date of first documented progression up to 24 months)
- Quality of life assessed by Questionnaire(one year by questionnaire)