NCT06753136 Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
| NCT ID | NCT06753136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Condition | Primary Visceral Tumors of Any Histotype |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2030-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2025-07-23 with a primary completion date of 2030-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06753136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Primary Visceral Tumors of Any Histotype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06753136 currently recruiting?
Yes, NCT06753136 is actively recruiting participants. Contact the research team at francesco.russano@iov.veneto.it for enrollment information.
Where is the NCT06753136 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT06753136 clinical trial?
NCT06753136 is sponsored by Istituto Oncologico Veneto IRCCS. The trial plans to enroll 24 participants.