RecruitingNot ApplicableNCT06753136

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

Treatment of Visceral Localizations With Electrochemotherapy in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype: Monocenter, Single Arm, Clinical Investigation

Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

24 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

Liver Cancer Melanoma Merkel Cell Carcinoma Squamous Cell Carcinoma Liver Metastasis Colon Cancer Non-melanoma Skin Cancer Primary Visceral Tumors of Any Histotype Visceral Lesions Primary Pancreatic Tumor Retroperitoneal Sarcoma Abdominal and/or Peritoneal Localizations Secondary Visceral Localizations of Any Histotype

Summary

This is an monocenter, single arm, clinical investigation that evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. Electrochemotherapy is a well-defined method for the treatment of cutaneous and subcutaneous metastases of different tumor histotypes. Although still limited, the various experiences in the treatment of visceral localizations, particularly in liver metastases from colorectal cancer are promising and show that electrochemotherapy is a safe treatment, even in the case of lesions near large vessels or nerves. The investigators therefore propose a clinical investigation with a Medical Device according to EU Regulation 745/2017, using electrochemotherapy (Cliniporator) with bleomycin for the treatment of visceral, primary or secondary, unresectable localizations, with percutaneous or intraoperative technique (laparoscopic or laparotomy), as needed.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests electrochemotherapy (ECT) — a procedure that uses brief electrical pulses to help cancer-fighting drugs enter tumor cells more effectively — in patients with tumors inside the body (visceral metastases) that cannot be cured with standard treatments. **You may be eligible if...** - You are 18 or older - You have confirmed primary or secondary cancer inside the body (visceral localizations of any type) - You are not a candidate for standard curative surgery or treatment **You may NOT be eligible if...** - You have cancer that has spread to the brain, lungs, or bones - You have uncorrectable blood clotting problems - You are allergic to bleomycin (the drug used in the procedure) or have any absolute contraindication to it - You have poor lung function or pulmonary fibrosis - You have an active lung infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEpercutaneous, laparoscopic or laparotomy lesion electrochemotherapy

All patients will receive Bleomycin intravenously with a dosage of 15.000 IU/m2. After a drug distribution time of 8 minutes, the lesions will be electroporated using the Cliniporator (IGEA S.P.A., Carpi, Italy), applying special handpieces depending on the route used: laparoscopic electrode, flexible and expandable for the laparoscopic procedure, linear or hexagonal electrode for laparotomy surgical access, variable geometry electrode for percutaneous access. The ECT procedure must be completed within 40 minutes.