NCT07404605 Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma
| NCT ID | NCT07404605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | MELANOMA |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2023-09-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07404605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying MELANOMA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07404605 currently recruiting?
Yes, NCT07404605 is actively recruiting participants. Contact the research team at kkorosec@onko-i.si for enrollment information.
Where is the NCT07404605 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07404605 clinical trial?
NCT07404605 is sponsored by Institute of Oncology Ljubljana. The trial plans to enroll 150 participants.
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