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Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
Sponsor: Istituto Oncologico Veneto IRCCS
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-07-23
Completion Date
2030-02-28
Last Updated
2025-08-06
Healthy Volunteers
No
Conditions
Interventions
percutaneous, 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.
Locations (1)
Istituto Oncologico Veneto
Padova, Italy