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

Istituto Oncologico Veneto IRCCS

Status: Enrolling

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

Treatments: Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06753136

IOV-VL-01-2024-ECT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

electrochemotherapy

Experimental group

Description:

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.

Treatment:

Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy