NCT02929797Unknown早期 1 期
A Randomized, Double Blinding, Placebo-Controlled Clinical Trials of CD8+NKG2D+ AKT Cell Immunotherapy to the Pancreatic Cancer Patients Treated With Adjuvant Chemotherapy
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.
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
- •Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology;
- •Pancreatic cancer after radical resection;
- •Eastern Cooperative Oncology Group Performance Status less than 2;
- •Without radiotherapy or neoadjuvant chemotherapy;
- •The man or the gestation and lactation women Age between 18 to 80 years old;
- •Bone marrow functioned well: ANC more than 1.5*10^9/ L, PLT more than 100*10^9/LHgb more than 9 g/dL;
- •Blood biochemical indicators: AST（SGOT）less than 1.5 ULNALT（SGPT）less than 1.5 ULN, TBIL less than 1.5 ULN;
- •PT and PPT are in normal ranges;
- •Three months prior to clinical research did not receive any other clinical research trials;
- •patients are voluntary, and willing to sign informed consent.
排除标准
- •Patients with other malignant tumors in the past five years;
- •Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment;
- •Known as HIV infection, active hepatitis B virus or hepatitis C virus infection;
- •Known allergy to any kind of component of study drugs;
- •History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis);
- •Patients with a history of interstitial pneumoniaSlowly progressive difficulty in breathing and hoose Sarcoidosissilicosis Fibrose pulmonaire idiopathiquehylactic pneumonia or A variety of allergy;
- •Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements;
- •At the same time Patients participate in any other use of interventional medicine clinical research or checkers.
研究组 & 干预措施
AKT + gemcitabine
Experimental
gemcitabine dose 1000mg/M^2, d1,8,15，q4w ×6 AKT 5*10^8/M^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell
干预措施: CD8+NKG2D+ AKT Cell (Biological)
AKT + gemcitabine
Experimental
gemcitabine dose 1000mg/M^2, d1,8,15，q4w ×6 AKT 5*10^8/M^2, d16,q4w ×6 Drug: gemcitabine Biological: AKT, CD8+NKG2D+ AKT Cell
干预措施: Gemcitabine (Drug)
gemcitabine
Active Comparator
gemcitabine hydrochloride dose 1000mg/M2 d1,8,15，q4w ×6 Drug: gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Disease-free survival
时间窗: 1 year
次要结局
- Quality of life(3 years)
- Overall Survival(3 years)
- immune indices(1 year)
研究者
Hongxia Wang
Deputy Director of Oncology
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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