Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)

Pregnancy or breastfeeding

Severe comorbidities preventing electrochemotherapy

Inability to comply with study procedures

Trial design

Treatments tested in this trial

  • Electrochemotherapy

Treatment groups

150 Participants
are divided into 1 treatment group