NCT02702986已完成1 期
Immunostimulating Interstitial Laser Thermotherapy in Patients With Locally Advanced Pancreatic Cancer: Results of a Prospective, Open, Non Comparative Study
Universita di Verona2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
10 Patients with Locally Advanced Pancreatic Cancer, no further responsive to neoadjuvant treatments but with a Stage-III disease will be submitted to imILT (Immunostimulating Interstitial Laser Thermotherapy). Safety and feasibility of imILT on LAPC will be evaluated as primary objective. Secondary objectives will be QoL after imILT, study of the immune reaction after imILT, oncological analysis of patients suffering from LAPC submitted to imILT.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage III locally advanced pancreatic cancer
- •No further neoadjuvant treatments are doable
- •Eastern Cooperative Oncology Group performance status < 1
排除标准
- •No other concomitant oncological treatments (hormonal, immunotherapies, etc)
- •Suffering from other neoplasms
- •Suffering from HIV
- •Suffering from autoimmune diseases
- •Concomitant medication with steroids
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Up to 24 months
次要结局
- Disease specific survival (DSS)(Up to 24 months)
- Progression free survival (PFS)(Up to 24 months)
- The immunostimulating effects of imILT(Up to 24 months)
- Overall Survival(Up to 24 months)
研究者
Salvatore Paiella, MD
MD
Universita di Verona
研究点 (2)
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