To Evaluate the Safety & Palliative Treatment Effect on Patients With Solid Cancers by Immunostimulating Interstitial Laser Thermotherapy (imILT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Treatment effect (Measurement of tumor burden by irRC criteria)
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 immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient.
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 solid tumors. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects. Since immunologically based treatment of various solid tumors is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens.
The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes.
This trial is explorative, prospective, open and non-randomized. Thirty patients diagnosed with solid tumors will be treated in this trial, which is estimated to be carried out during a time period of 18 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female > 18 years of age
- •Have histologically confirmed, locally uncontrolled, solid cancer, with or without metastases, that cannot be treated surgically due to unresectability or inoperability
- •Have one or more tumours assessable by MRI/CT or ultrasound and situated in such a way that at least a part of the tumour can be treated with IMILT without damage to surrounding vital structures or the skin
- •Are candidates for ablative intervention also outside this study
- •Have given informed verbal and written consent to participation in the trial
- •Have an ECOG performance status < 2 (Karnofsky > 60%)
- •Have stable haematologic, renal and hepatic functions
排除标准
- •Are HIV positive
- •Have an active autoimmune disease
- •Are on systemic corticosteroid medication (local treatment with aerosol's and ointment is allowed)
- •Have known bleeding disorders or are treated with anticoagulant medication
- •Are pregnant or nursing
研究组 & 干预措施
imILT
Immunostimulating Interstitial Laser Thermotherapy (imILT)
干预措施: Immunostimulating Interstitial Laser Thermotherapy (Device)
结局指标
主要结局
Treatment effect (Measurement of tumor burden by irRC criteria)
时间窗: 18 months
Measurement of tumor burden by irRC criteria.
次要结局
- Inflammatory response in tumor measured by quantification of inflammatory cell populations(18 months)
- Inflammatory response in circulation measured by quantification of inflammatory cell populations(18 months)
- Safety (adverse events)(18 months)
- Evaluation of pain (measured by VAS)(18 months)
- Evaluation of Quality of Life (using a standardized questionnaire)(18 months)
- Usability of the device as evaluated by treatment logs(18 months)