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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Istituto Oncologico Veneto
RECRUITING
Padua
Contact Information
Primary
Francesco Russano, MD
francesco.russano@iov.veneto.it
049 8211693
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 24
Treatments
Experimental: electrochemotherapy
Patients who meet the inclusion criteria will undergo percutaneous, laparoscopic or laparotomy lesion electrochemotherapy within 30 days from the time of obtaining informed consent for study participation (T0), during pre-surgery visit.The ECT will be performed in accordance with the Standard Operating Procedures (SOPs).During the first month after treatment, the patient's response will be assessed every 2 weeks, and thereafter, once a month for a total of 12 months.
Sponsors
Collaborators: IGEA
Leads: Istituto Oncologico Veneto IRCCS

This content was sourced from clinicaltrials.gov