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Recruiting NCT06753136

Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype

No phase Interventional Primary Visceral Tumors of Any Histotype Visceral Lesions Liver Cancer Liver Metastasis Colon Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy.
Who it may be relevant to
Registry conditions: Primary Visceral Tumors of Any Histotype, Visceral Lesions, Liver Cancer, Liver Metastasis Colon Cancer. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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).

Interventions

  • 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

Primary outcome measures

  • Primary objective and endpoint [Time frame: through study completion, an average of 5 year]
Secondary outcome measures (4)
  • Secondary objective and endpoints [Time frame: through study completion, an average of 5 year]
  • Secondary objective and endpoints [Time frame: through study completion, an average of 5 year]
  • Secondary objective and endpoints [Time frame: through study completion, an average of 5 year]
  • Secondary objective and endpoints [Time frame: through study completion, an average of 5 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Istituto Oncologico Veneto — Padova

Identifiers

NCT: NCT06753136 · IOV-VL-01-2024-ECT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗