Electrochemotherapy for unresectable visceral tumors including liver metastases
Official title: 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
Run by Istituto Oncologico Veneto IRCCS · NCT06753136 · Data updated 2026-11-12
This will try electrochemotherapy with bleomycin in adults who have unresectable primary or metastatic visceral tumors, such as liver metastases.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Istituto Oncologico Veneto IRCCS Academic / other |
| Locations | 1 site (Padova) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | January 31, 2030 |
| Study ends | February 28, 2030 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06753136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with unresectable primary or secondary visceral lesions of any histotype who are not eligible for curative surgery and can tolerate bleomycin and an invasive procedure.
✕Probably not a fit
Patients with active brain, lung, or bone metastases, uncorrectable coagulation problems, bleomycin allergy or contraindication, poor respiratory function, or who are pregnant or breastfeeding are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, single-arm clinical investigation enrolling at least 24 adult patients with primary or secondary visceral tumors of any histotype, with emphasis on liver metastases, pancreatic tumors, and retroperitoneal sarcomas. Patients receive electrochemotherapy using the Cliniporator device with bleomycin delivered by percutaneous or intraoperative approaches (laparoscopic or open) as clinically indicated. The primary outcome is objective response rate of treated visceral lesions following the procedure. Key exclusions include active brain, lung, or bone metastases, bleomycin contraindications or allergy, uncorrectable coagulation disorders, and poor pulmonary function.
Why it matters
Potential benefit: If successful, it could offer a local treatment option to shrink or control unresectable visceral tumors and relieve symptoms without major additional surgery.
How similar studies have gone: Electrochemotherapy is well established for cutaneous metastases, and limited single-center reports—particularly for colorectal liver metastases—have shown promising safety and tumor responses for visceral applications.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Istituto Oncologico Veneto
Padova, Italy Recruiting
Study contacts
- Study coordinator: Francesco Russano, MD
- Email: francesco.russano@iov.veneto.it
- Phone: 049 8211693
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.