About this trial
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 criteria
Qualifiers
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
Disqualifiers
Absolute contraindications to invasive procedures
Concomitant presence of brain, lung, bone metastases
Uncorrectable coagulation changes
Bleomycin allergy
Trial design
Treatments tested in this trial
- percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
Treatment groups
Locations
1Sponsors and collaborators
Istituto Oncologico Veneto IRCCS
Lead sponsor
IGEA
Collaborator