A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- overall surviva
研究概览
简要总结
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.
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
- •Signed written informed consent
- •Karnofsky score > 60,
- •Expected survival > 3 months,
- •Liver, kidney function and routine blood test within normal range
- •No serious cardiopulmonary dysfunction
- •No acute infection
排除标准
- •Pregnant or lactating women
- •Uncontrolled internal diseases
- •Past or the presence of other malignancy
- •Those who had received immunosuppressive therapy
结局指标
主要结局
overall surviva
时间窗: 36 months
次要结局
- Clinical Benefit Rate(12 months)
- The median progression-free survival PFS(12 months)
- Drug Toxicity(18 months)
- surgical complications(18 months)
研究者
Guohong Han
Head of Department of Digestive Interventional Radiology
Air Force Military Medical University, China