RecruitingNot ApplicableNCT07404605

Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma

Electrochemotherapy Induces Changes in Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma


Sponsor

Institute of Oncology Ljubljana

Enrollment

150 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • Contraindication to electrochemotherapy or study drugs (bleomycin or cisplatin)
  • Pregnancy or breastfeeding
  • Severe comorbidities preventing electrochemotherapy
  • Inability to comply with study procedures

Interventions

PROCEDUREElectrochemotherapy

Electrochemotherapy 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.


Locations(1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

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NCT07404605


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