Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population.
研究概览
简要总结
In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.
详细描述
In this non randomized phase II study, we will explore histopathological tumour cell death mechanisms in 24 patients with breast cancer metastases or other cutaneous or subcutaneous malignancy. The primary endpoint of the biopsy study is to evaluate differences in tumour infiltrating lymphocyte (TIL) population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to samples taken on the day of treatment before the calcium electroporation procedure. TIL content in biopsies will be evaluated by pathological examination and specified in percent of cells. Patients will be followed up to 3 months and depending on number of treated tumors, biopsies will be taken at different timepoints after one or two treatments with calcium electroporation. Other analyses will include differences regarding tumour type, immune marker expression levels over time, vascular effects and regressive changes as well as examining changes in systemic immunological markers.
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
- •Trial subject must be able to understand the participant information.
- •Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
- •The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.).
- •The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area.
- •Performance status ECOG/WHO ≤2
- •At least one cutaneous or subcutaneous tumour measuring at least 5 mm.
- •Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.)
- •Signed informed consent.
排除标准
- •Pregnancy or lactation
- •Allergy to local anaesthesia
结局指标
主要结局
The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population.
时间窗: 2 days
The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment (biopsy taken on the day of treatment before the calcium electroporation procedure). TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.
次要结局
- Changes in immune markers(3 months)
- Tumour inflammation signature (TIS)(3 months)
- Size of lesion(3 months)
- Clinical response to intervention(3 months)
- PD-L1 expression in relation to cell types(3 months)
- TIL population and tumour type(3 months)
- Vascular effects(3 months)
- Importance of previous irradiation(3 months)
- Adjacent non-tumour tissue(3 months)
- PD-L1 expression over time(3 months)
- Relation between change in PD-L1 expression and response(3 months)
- Current measurement(1 month)
- Complete disappearance of treated lesions (in relation to all lesions treated)(3 months)
- Tumour type(3 months)
- Tumour regression(3 months)
- PD-L1 expression of different tumour histologies(3 months)
- Systemic immune factors after calcium electroporation(3 months)
- PCR(3 months)
- Molecular subtype classification(3 months)
- Residual tumour(3 months)
- Complete response at patient level(3 months)
- Systemic immunologic response(3 months)
- Western blotting(3 months)