Clinical Study of Electrochemotherapy Using Bleomycin for Treating Primary and Secondary Visceral Tumors of Various Types

What this Trial Is About

Researchers are evaluating electrochemotherapy ECT using the Cliniporator device combined with bleomycin for treating patients with primary or secondary visceral tumors of any histotype. This single-center clinical investigation focuses on patients with unresectable visceral lesions, especially liver cancer, liver metastases from colorectal cancer and melanoma, pancreatic tumors, retroperitoneal sarcomas, and various abdominal or skin cancer localizations. The study aims to assess the objective response rate ORR of visceral lesions treated with ECT, building on promising safety data from previous treatments of cutaneous and subcutaneous metastases. Participants will receive percutaneous, laparoscopic, or open surgery laparotomy electrochemotherapy according to standard procedures. Bleomycin will be administered intravenously at a dose of 15,000 IUm2, followed by lesion electroporation using specialized electrodes based on the treatment route. The entire ECT procedure is completed within 40 minutes. Treatment occurs within 30 days of informed consent during a pre-surgery visit. After treatment, patients will have their response evaluated every two weeks during the first month, then monthly for up to 12 months. Researchers will monitor the safety, effectiveness, and other outcomes for an average of five years. This includes regular follow-ups and assessments to track the impact of ECT on the tumors and overall patient health throughout the study duration.

Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype