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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Electrochemotherapy
Procedure/SurgeryElectrochemotherapy is performed according to standard clinical procedures with application of electric pulses combined with administration of cytotoxic agents (intravenous bleomycin or intratumoral cisplatin) for treatment of cutaneous and subcutaneous melanoma metastases.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Electrochemotherapy (ECT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Tumor Microenvironment Biomarker Panel 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.
Time frame
Baseline (pre-treatment) and post-treatment (up to 3 months after electrochemotherapy)Secondary outcomes
1
Difference in Tumor Microenvironment Biomarkers Between Treated and Untreated Lesions
Comparison of a predefined panel of tumor microenvironment biomarkers (including immune cell infiltration markers and vascular markers) between electrochemotherapy-treated lesions and untreated lesions in the same patient.
Time frame
Up to 3 months after electrochemotherapy2
Local Tumor Control Rate After Electrochemotherapy
Local tumor control of electrochemotherapy-treated cutaneous and subcutaneous melanoma metastases assessed clinically and/or radiologically.
Time frame
Up to 12 months after electrochemotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov