Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma
Recruiting · NCT07404605 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Oncology Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)
- Pregnancy or breastfeeding
- Severe comorbidities preventing electrochemotherapy
- Inability to comply with study procedures
Where it is running
1 location listed.
- Institute of Oncology Ljubljana - Ljubljana, Slovenia