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NCT Number: NCT06753136

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.

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Key information

Conditions

Primary Visceral Tumors of Any Histotype Abdominal and/or Peritoneal Localizations Adenocarcinoma Carcinoma Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Squamous Cell DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Infections Liver Cancer Liver Diseases Liver Metastasis Colon Cancer Liver Neoplasms Melanoma Merkel Cell Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-Melanoma Skin Cancer Polyomavirus Infections Primary Pancreatic Tumor Retroperitoneal Sarcoma Secondary Visceral Localizations of Any Histotype Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma Tumor Virus Infections Virus Diseases Visceral Lesions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Oncologico Veneto

Padova, 35128, Italy

Location status: Recruiting

Location contact

Francesco Russano, MD

CONTACT

[email protected]

049 8211693

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous, laparoscopic or laparotomy lesion electrochemotherapy

Device

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 outcomes

  1. Primary objective and endpoint

    Time frame: through study completion, an average of 5 year

    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.

Secondary outcomes

  1. Secondary objective and endpoints

    Time frame: through study completion, an average of 5 year

    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.

  2. Secondary objective and endpoints

    Time frame: through study completion, an average of 5 year

    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.

  3. Secondary objective and endpoints

    Time frame: through study completion, an average of 5 year

    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.

  4. Secondary objective and endpoints

    Time frame: through study completion, an average of 5 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Russano, MD

CONTACT

[email protected]

049 8211693

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Collaborators

  • IGEA

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 31, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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