Primary Visceral Tumors of Any HistotypeNCT06753136
Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
A study testing percutaneous, laparoscopic or laparotomy lesion electrochemotherapy in people with Primary Visceral Tumors of Any Histotype and Visceral Lesions, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary Visceral Tumors of Any Histotype, Visceral Lesions, Liver Cancer
- What is being tested?
- percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jul 2025to 28 Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Oncologico Veneto
Padova, 35128
Francesco Russano, MD, 049 8211693, francesco.russano@iov.veneto.it
About this study
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
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.
Read the 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).
- Conditions
- Primary Visceral Tumors of Any Histotype, Visceral Lesions, Liver Cancer, Liver Metastasis Colon Cancer, Melanoma, Primary Pancreatic Tumor
- Being tested
- percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
- Keywords
- electrochemotherapy, visceral lesions, Laparoscopic procedure, Laparotomic procedure, Percutaneous procedure, bleomycin, medical device
- Medical subject headings
- Liver Neoplasms, Melanoma, Carcinoma, Merkel Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous, laparoscopic or laparotomy lesion electrochemotherapyDevice
All patients will receive Bleomycin intravenously with a dosage of 15.000 IU/m2. After a drug distribution time of 8 minutes, the lesions will be electroporated using the Cliniporator (IGEA S.P.A., Carpi, Italy), applying special handpieces depending on the route used: laparoscopic electrode, flexible and expandable for the laparoscopic procedure, linear or hexagonal electrode for laparotomy surgical access, variable geometry electrode for percutaneous access. The ECT procedure must be completed within 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| electrochemotherapy | Experimental | 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. Receives: Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective and endpoint
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.
Measured: through study completion, an average of 5 year
Secondary outcomes (4)
Secondary objective and endpoints
Evaluate the conversion rate of "unresectable disease" to "resectable disease" after ECT treatment. The conversion from "unresectable disease" to "resectable disease" is defined by the number of patients, declared inoperable with the intent of surgical radicality due to the extent of the disease and/or the involvement of non-removable structures and who become operable for surgery with the intent of radical excision following response after an electrochemotherapy treatment.
Measured: through study completion, an average of 5 year
Secondary objective and endpoints
Assess progression-free time (PFS). Progression-free survival (PFS) is defined as the time from study enrollment to the first documentation of objective disease progression or death due to any cause, whichever occurs first. Documentation of disease progression is defined according to RECIST v1.1 criteria, based on investigator assessment. PFS will be censored at the time of the last tumor evaluation documenting the absence of progression for patients who are alive and progression-free at the time of analysis. Live patients who have no tumor assessments after baseline will have time to the censored event on the date of study enrollment.
Measured: through study completion, an average of 5 year
Secondary objective and endpoints
Assess overall survival (OS). Overall survival (OS) is defined as the time (quantified in months) from enrollment in the study to the date of the subject's death from any cause. For subjects living at the end of the study, the last follow-up date will be considered.
Measured: through study completion, an average of 5 year
Secondary objective and endpoints
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.
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start23 Jul 2025
- Primary completion31 Jan 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Visceral Tumors of Any HistotypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- IGEA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753136
- Sponsor's protocol ID
- IOV-VL-01-2024-ECT
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided