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Electrochemotherapy-Induced Changes in Tumor Microenvironment in Cutaneous Melanoma

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint revised Secondary endpoints revised (2)v2 Show 1 more changeShow less
    • Secondary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07404605
Lead Sponsor Institute of Oncology Ljubljana
Conditions MELANOMA, SKIN NEOPLASMS
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov