Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Pancreatic Carcinoma Patient
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
研究概览
简要总结
The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.
详细描述
In the study, after evaluation of the general and physical status, eligible patients will be enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line (control group) and in experimental arm, patients will be receiving simultaneous standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease progression.
Blood sample will be obtained at baseline and every week before MV injection for the assessment of clinical hematology, biochemistry measurements and immunology index (including immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout the study. Side effect, progression free survival, immunology index and general status will be recorded.
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 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients diagnosed with pancreatic carcinoma based on histology
- •2.Evaluable lesions on imaging study
- •3.Without known immunodeficiency
- •4.Age >18 and <80 years ago
排除标准
- •1.Patients is unable or unwilling to sign informed consent
- •2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
- •3.Positive HIV and/or RPR (rapid plasma reagin)
- •4.Female patient who is pregnant or breast feeding
- •5.Patients, based on the opinion pf the investigator, should not be enrolled into this study
- •6.Prior anti-cancer vaccine or biological immunotherapy
- •7.Allergic to any known ingredient of the MV compound
研究组 & 干预措施
control
Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line
干预措施: Standard Treatment (Other)
MV+control
Patients in this group will be receiving both standard therapy according to NCCN guide line and simultaneous injection of mix vaccine (MV).
干预措施: MV (Biological)
MV+control
Patients in this group will be receiving both standard therapy according to NCCN guide line and simultaneous injection of mix vaccine (MV).
干预措施: Standard Treatment (Other)
结局指标
主要结局
efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
时间窗: 2 years
次要结局
- immunology index(2 years)
- safety as measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria(1 month)