Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Safety (adverse events)
研究概览
简要总结
Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.
The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.
This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.
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
- •Cytohistological diagnosis of ductal pancreatic adenocarcinoma .
- •Stage III disease (see above).
- •The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due to lack of demonstrable efficiency or to the side effects of the drugs.
- •Age between 18 and 80 years.
- •Anticipated compliance with treatment and follow-up.
- •Double informed consent for both imILT and possible surgery with radical intent (in the event of pre-operative overstaging).
- •At least a part of the tumor can be treated with imILT without damage to surrounding vital structures.
- •Have an ECOG performance status < 1 (l'Eastern Cooperative Oncology Group)
排除标准
- •Not a candidate for laparotomy.
- •Becoming resectable after neoadjuvant chemotherapy.
- •Other simultaneous treatments for the same neoplasm.
- •Simultaneous other malignancies except for basal cell carcinoma.
- •HIV positive.
- •Active autoimmune disease.
- •Systemic corticosteroid medication.
- •Pregnancy or nursing.
结局指标
主要结局
Safety (adverse events)
时间窗: 36 months
Evaluation of adverse events.
次要结局
- Disease progression(36 months)
- Usability of the device as evaluated by treatment logs(36 months)
- Evaluation of Quality of Life (using questionnaires)(36 months)
- Inflammatory response in circulation measured by quantification of inflammatory cell populations(36 months)