EUS-guided Intratumoral Gemcitabine Therapy in Locally Advanced Unresectable Pancreatic Cancer: A Phase 1 Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.
详细描述
In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
排除标准
- •Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
- •Pancreatic cancer with distant metastasis
- •Unwilling to sign informed consent
研究组 & 干预措施
Intratumoral gemcitabine injection
Intratumoral injection of gemcitabine by means of endoscopic ultrasound.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 6 months
次要结局
- Proportion of participants who remain alive one year after enrollment compared to the historical matched control group(1 year)
研究者
Mehdi Mohamadnejad
Assistant Professor of Medicine
University of Tehran