An interventional study of percutaneous, laparoscopic or laparotomy lesion electrochemotherapy in Primary Visceral Tumors of Any Histotype, Visceral Lesions and Liver Cancer, sponsored by Istituto Oncologico Veneto IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Istituto Oncologico Veneto IRCCS · Not applicable, Interventional, and Treatment
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Among 79 studies in Liver Neoplasms with a site in Italy — 17 open to participants now, 26 under way, 4 of them phase 3. Liver Neoplasms · Italy.
Among the 79 studies in Liver Neoplasms with a site in Italy, this one is the 49th largest by planned enrollment of the 53 interventional ones that give a count, is the only one that started in 2025, is one of 15 with no phase, reaches primary completion later than 19 of the 25 other live ones, and was the 73rd registered.
1,345 studies on the registry are indexed under Liver Neoplasms; 334 are open to participants now.
Browse Liver Neoplasms studies →17 of the 79 studies in Liver Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 18–64
Alnylam Pharmaceuticals · Sites in Italy, United States, Korea, Republic of
Ages 18+
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 18+
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 18+
Maastricht University · Sites in Italy, United States, Australia and 6 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 243 Liver Neoplasms studies recruiting now, 137 (56%) set no upper age limit and 69 (28%) stop at 75 or younger; 14 take children under 18; 34 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
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79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 12 · Phase 3 20
First in 1998; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 47 across 928 interventional studies indexed under Liver Neoplasms.
Median enrollment 140 across the 53 interventional studies, 500 across the 25 observational. Of the 46 that completed or were terminated, 17 (37%) have results posted.
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40 of 79 have an industry lead sponsor. The 10 most frequent:
Istituto Oncologico Veneto IRCCS is the lead sponsor of 47 studies on the registry; 13 are open to participants now.
Istituto Oncologico Veneto IRCCS has 1 study filed under Liver Neoplasms — fewer than ten, so there is no comparison to draw.
5 of the studies in Liver Neoplasms with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07750275University of MoliseSafety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery | 2026-12 |
| NCT02954094Target PharmaSolutions, Inc.A Longitudinal Observational Study of the Natural History and Management of Patients With HCC | 2027-02 |
| NCT04008797Eisai Inc.A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor | 2027-03-31 |
| NCT05063565Boston Scientific CorporationTheraSphere With Durvalumab and Tremelimumab for HCC | 2027-06 |
| NCT06600321Alnylam PharmaceuticalsA Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma | 2027-09-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 79 studies in Liver Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
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.
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.
Time frame: through study completion, an average of 5 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 5 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jan 2030, 54 months after the start.
Of 149 non-industry interventional studies with no phase under Liver Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 82. This study's planned 54 months is above that.
Counting every sponsor, half of 168 studies reached it within 39 months; a quarter within 18 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
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Istituto Oncologico Veneto IRCCS