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

NCT06753136 | Recruiting

• 1 other identifier: IOV-VL-01-2024-ECT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

electrochemotherapy; visceral lesions; Laparoscopic procedure; Laparotomic procedure; Percutaneous procedure; bleomycin; medical device

Outcome Measures

Primary Outcomes (1)

• Primary objective and endpoint

  Evaluate the impact of the method on the objective response rate (ORR) of visceral lesions undergoing electrochemotherapy. ORR is defined as the proportion of patients, out of the total enrolled subjects, who achieved a complete response (CR) or partial response (PR) response, based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Determination of radiological response will be based on the assessment reported by the investigator. Radiological responses will be assessed every 8 weeks starting with cycle 1 day 1 of treatment until disease progression, withdrawal of consent, or death for any reason, whichever occurs first.

  through study completion, an average of 5 year

Secondary Outcomes (4)

• Secondary objective and endpoints

  through study completion, an average of 5 year

• Secondary objective and endpoints

  through study completion, an average of 5 year

• Secondary objective and endpoints

  through study completion, an average of 5 year

• Secondary objective and endpoints

  through study completion, an average of 5 year

Study Arms (1)

electrochemotherapy

EXPERIMENTAL

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.

Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy

Interventions

percutaneous, laparoscopic or laparotomy lesion electrochemotherapy 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.

electrochemotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead
• IGEA: collaborator

Study Sites (1)

Istituto Oncologico Veneto

Padova, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Melanoma; Carcinoma, Merkel Cell; Carcinoma, Squamous Cell

Interventions

Administration, Cutaneous; Laparoscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Francesco Russano, MD

CONTACT

049 8211693; francesco.russano@iov.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IT (1)