NCT02529579Unknown1 期
Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- 6-month SR
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced Pancreatic cancer patients with histological pathology confirmation
- •Both gender, aged 18-70 year-old
- •Bone marrow functioned well
- •Renal function normal
- •Liver function normal
- •patients are voluntary, and willing to sign informed consent
- •expected lifetime was at least 3 months
排除标准
- •With acute inflammation
- •Accompanied with primary malignant tumor other than pancreas
- •with autoimmune disease
- •using corticosteroid or other suppress immune hormone treatment
- •had transplant operation of vital organs
- •active hepatitis
- •HIV positive
- •dysfunction in blood coagulation
- •serious diseases in circulatory and respiratory systems
- •pregnancy or breast-feeding women
研究组 & 干预措施
Gemcitabine
Active Comparator
Standard Gemcitabine Therapy
干预措施: Gemcitabine (Drug)
cellular immunotherapy & Gemcitabine
Experimental
iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy
干预措施: iAPA-DC/CTL adoptive cellular immunotherapy (Other)
cellular immunotherapy & Gemcitabine
Experimental
iAPA-DC/CTL adoptive cellular immunotherapy combined Standard Gemcitabine Therapy
干预措施: Gemcitabine (Drug)
结局指标
主要结局
6-month SR
时间窗: 6 months
6 months survival rate
次要结局
- ORR(2 months)
- PFS(6 months)
- OS(6 months)
- QOL(2 months)
研究者
Zhaoshen Li
director of department of gastroenterology
Changhai Hospital
研究点 (1)
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