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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIstituto Oncologico Veneto IRCCS

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

24 Participants
are divided into 1 treatment group

Locations

1
Istituto Oncologico Veneto35128, Padova Italy

Sponsors and collaborators

Istituto Oncologico Veneto IRCCS

Lead sponsor

IGEA

Collaborator