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

NCT ID: NCT06753136

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-23
• Study Completion Date: 2030-02-28

Brief 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.

Detailed Description

This is a single-center clinical investigation with the enrollment of at least 24 patients with visceral, primary or secondary localizations, of any histotype, with particular reference to liver cancer, liver metastases from colorectal cancer and melanoma, primary pancreatic tumors, retroperitoneal sarcomas, abdominal and/or peritoneal localizations from melanoma and non-melanoma skin cancer (Merkel cell carcinoma, Squamous cell ca).

Conditions

Primary Visceral Tumors of Any Histotype; Visceral Lesions; Liver Cancer; Liver Metastasis Colon Cancer; Melanoma; Primary Pancreatic Tumor; Retroperitoneal Sarcoma; Abdominal and/or Peritoneal Localizations; Merkel Cell Carcinoma; Squamous Cell Carcinoma; Secondary Visceral Localizations of Any Histotype; Non-melanoma Skin Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

percutaneous, laparoscopic or laparotomy lesion electrochemotherapy

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGEA

INDUSTRY

Sponsor Role: collaborator

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Oncologico Veneto

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Russano, MD

Role: CONTACT

francesco.russano@iov.veneto.it

049 8211693

Facility Contacts

Francesco Russano, MD

Role: primary

francesco.russano@iov.veneto.it

049 8211693

Other Identifiers

IOV-VL-01-2024-ECT

Identifier Type: -

Identifier Source: org_study_id