Electrochemotherapy Treatment for Recurrent Gynecological Cancers Phase 2 Study Evaluating Safety and Effectiveness For Women Aged 18 to 105 Years

What this Trial Is About

Researchers are evaluating the effectiveness, feasibility, and safety of electrochemotherapy for treating local and regional recurrences of gynecological cancers in patients who have exhausted standard treatment options. This phase 2 interventional study focuses on patients with gynecological tumors that have relapsed locally or regionally where no other treatments remain viable. The study involves electrochemotherapy using bleomycin or cisplatin. Treatment is delivered under anesthesia, and patients must be suitable candidates for this procedure. The trial includes regular follow-up to assess tumor response and safety outcomes over a period of up to 24 months. Participants will undergo evaluations of tumor changes based on RECIST 1.1 criteria and safety monitoring according to CTCAE v5.0 criteria during hospitalization and throughout the 24-month follow-up. Patients will be assessed for life expectancy, performance status, and other health factors before enrollment. The study aims to monitor responses and adverse reactions related to electrochemotherapy treatment in this patient group.

Electrochemotherapy of Gynecological Cancers