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2025-07-23
2030-01-31
2030-02-28
24
NCT06753136
Istituto Oncologico Veneto IRCCS
Istituto Oncologico Veneto IRCCS
INTERVENTIONAL
Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-17 | N/A | 2025-08-05 |
2024-12-20 | N/A | 2025-08-06 |
2024-12-31 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: electrochemotherapy 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 per | DEVICE: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 5 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | through study completion, an average of 5 year |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Francesco Russano, MD Phone Number: 049 8211693 Email: francesco.russano@iov.veneto.it |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
