Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma

Recruiting now · Not applicable

Conditions studied: MELANOMA, SKIN NEOPLASMS

In brief

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.

Key facts

Study ID

NCT07404605

Run by

Institute of Oncology Ljubljana

People needed

150

Starts

2023-09-01

Expected to finish

2026-09-30

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Institute of Oncology Ljubljana — Ljubljana, Slovenia (enrolling)

Full record on ClinicalTrials.gov

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