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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Primary objective and endpoint — 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.

Trial sites (1)

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