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

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. 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.

Interventions

• 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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Istituto Oncologico Veneto, Padova, Italy · RECRUITING