Efficacy and Safety of Endoscopic Ultrasound Guided Fine-needle Injection of Dendritic Cells Vaccination Into Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pancreatic tumor response rates
研究概览
简要总结
Pancreatic cancer is the second most frequent gastrointestinal malignancy. The overall survival is dismal. Especially for advanced pancreatic cancer, the conventional approaches are typically not curative and provide only minor increases in survivals in most cases. Dendritic cells (DCs) are powerful antigen-presenting cells (APCs) that play a pivotal role in the initiation, programming, and regulation of tumor-specific immune responses. Isolated DCs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found to induce protective and therapeutic anti-tumor immunity in experimental animals. Some clinical trials of DC vaccination for cancer patients have shown the induction of anti-tumor immune responses and tumor regression. Endoscopic ultrasound (EUS) is an established technique for the diagnosis and staging of pancreatic cancer. Endoscopic ultrasound guided fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a promising treatment modality.Therefore, The purpose of the study is to evaluate the efficacy and safety of endoscopic ultrasound guided fine-needle injection of DCs vaccination into advanced pancreatic cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas.
- •Patients must be deemed unresectable due to involvement of important vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable.
- •Life expectancy of >3 months.
- •Karnofsky performance status >50%.
- •Patients must have adequate clotting and coagulation function (platelet > 100k; INR<1.4).
- •Able and willing to sign a written informed consent.
排除标准
- •Patients receiving anticoagulation therapy.
- •Steroids or immunosuppressing agent dependant status
- •Patients who have received prior gemcitabine or radiation therapy in the past 4 weeks
- •Ongoing infection
- •Pregnancy or breast-feeder
- •Other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions
- •Massive ascites
- •Decision of unsuitableness by principal investigator or physician-in-charge
结局指标
主要结局
pancreatic tumor response rates
时间窗: six months
次要结局
- survival rates(six month)
研究者
Ying Lv
Associate professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School