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
Istituto Oncologico Veneto IRCCS
24 participants
Jul 23, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Male/Female ≥ 18 years
- Ability to understand the proposed treatment and express an informed acceptance by signing the informed consent
- Diagnosis of primary and/or secondary visceral localizations of any histotype
- Patients who are not eligible for standard curative procedures
Exclusion Criteria8
- Absolute contraindications to invasive procedures
- Concomitant presence of brain, lung, bone metastases
- Uncorrectable coagulation changes
- Bleomycin allergy
- Absolute contraindications to taking Bleomycin
- Poor respiratory function or pulmonary fibrosis
- Acute lung infections
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06753136