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

Not Applicable

Not yet recruiting

• 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

• Registration Number: NCT06753136
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

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).

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-20
• Study First Posted: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Start: 2025-06-01
• Primary Completion: 2030-01-31
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary objective and endpoint	through study completion, an average of 5 year	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.

Secondary Outcome Measures

Name	Time	Method
Secondary objective and endpoints	through study completion, an average of 5 year	Evaluate the toxicity of electrochemotherapy treatment (ECT). Overall toxicity rate is defined as the proportion of patients, among those who received at least one dose of treatment, who experienced grade 3-4 adverse events, according to NCI CTCAE v5.

Trial Locations

Locations (1)

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy