Electrochemotherapy for unresectable visceral tumors including liver metastases
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
This will try electrochemotherapy with bleomycin in adults who have unresectable primary or metastatic visceral tumors, such as liver metastases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Istituto Oncologico Veneto IRCCS Academic / other |
| Locations | 1 site (Padova) |
| Trial ID | NCT06753136 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Padova
- Istituto Oncologico Veneto — Padova, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Russano, MD
- Email: francesco.russano@iov.veneto.it
- Phone: 049 8211693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.