Electrochemotherapy Induces Changes in Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Tumor Microenvironment Biomarker Panel After Electrochemotherapy
研究概览
简要总结
Cutaneous melanoma frequently develops cutaneous and subcutaneous metastases, which may cause significant morbidity and negatively affect quality of life. Electrochemotherapy (ECT) is an established local treatment modality for cutaneous and subcutaneous tumor lesions that combines the administration of cytotoxic drugs with the application of electric pulses to increase drug uptake into tumor cells.
In addition to its direct cytotoxic effects, electrochemotherapy may induce changes in the tumor microenvironment, including immune cell infiltration, vascular alterations, and other biological responses that could influence tumor control.
The aim of this study is to evaluate changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases following electrochemotherapy with either intravenous bleomycin or intratumoral cisplatin. Tumor tissue samples collected before and after treatment will be analyzed to characterize microenvironmental changes and to compare treated and untreated lesions.
The results of this study may improve understanding of biological effects of electrochemotherapy in melanoma metastases and support further development of treatment strategies.
详细描述
This is a prospective interventional clinical study designed to investigate electrochemotherapy-induced changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases.
Electrochemotherapy is a local treatment approach that combines electroporation with cytotoxic agents in order to increase intracellular drug delivery and enhance tumor cell death. The treatment is routinely used for superficial tumor lesions, including melanoma metastases, and can be performed using intravenous bleomycin or intratumoral cisplatin.
The primary objective of this study is to characterize changes in the tumor microenvironment in melanoma metastases following electrochemotherapy. Tumor tissue samples will be collected from untreated lesions and from lesions treated with electrochemotherapy. Histopathological and immunohistochemical analyses will be performed to evaluate changes in the tumor microenvironment, including cellular and stromal components, immune-related features, and other relevant biological markers.
The study will include patients with cutaneous melanoma presenting with cutaneous and/or subcutaneous metastases who are eligible for electrochemotherapy as part of their clinical management. Electrochemotherapy will be performed according to established clinical procedures using intravenous bleomycin or intratumoral cisplatin. Biopsy or surgical samples will be collected before and after treatment to enable comparative analyses of treated and untreated tumor tissue.
Collected clinical and pathological data will be used to assess associations between treatment-related microenvironmental changes and patient and lesion characteristics. The study aims to provide additional insight into biological effects of electrochemotherapy beyond local tumor control and may contribute to improved understanding of mechanisms involved in treatment response.
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
- •Adults aged 18 years or older
- •Histologically confirmed cutaneous melanoma
- •Presence of cutaneous and/or subcutaneous metastases eligible for electrochemotherapy
- •Candidate for electrochemotherapy with intravenous bleomycin or intratumoral cisplatin according to standard clinical practice
- •Ability to provide written informed consent
排除标准
- •Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)
- •Pregnancy or breastfeeding
- •Severe comorbidities preventing electrochemotherapy
- •Inability to comply with study procedures
研究组 & 干预措施
Electrochemotherapy (ECT)
Patients with cutaneous melanoma with cutaneous and/or subcutaneous metastases undergoing electrochemotherapy as part of clinical management. Electrochemotherapy is performed using intravenous bleomycin or intratumoral cisplatin. Tumor samples are collected before and after treatment for analysis of tumor microenvironment changes.
干预措施: Electrochemotherapy (Procedure)
结局指标
主要结局
Change in Tumor Microenvironment Biomarker Panel After Electrochemotherapy
时间窗: Baseline (pre-treatment) and post-treatment (up to 3 months after electrochemotherapy)
Change in a predefined panel of tumor microenvironment biomarkers assessed by histopathology and immunohistochemistry in tumor tissue samples collected before and after electrochemotherapy. Biomarkers include immune cell infiltration markers and vascular markers. Results will be reported separately for each biomarker.
次要结局
- Difference in Tumor Microenvironment Biomarkers Between Treated and Untreated Lesions(Up to 3 months after electrochemotherapy)
- Local Tumor Control Rate After Electrochemotherapy(Up to 12 months after electrochemotherapy)