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

ConditionsPrimary Visceral Tumors of Any HistotypeVisceral LesionsLiver CancerLiver Metastasis Colon CancerMelanomaPrimary Pancreatic TumorRetroperitoneal SarcomaAbdominal and/or Peritoneal LocalizationsMerkel Cell CarcinomaSquamous Cell CarcinomaSecondary Visceral Localizations of Any HistotypeNon-melanoma Skin Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIstituto Oncologico Veneto IRCCS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absolute contraindications to invasive procedures

Concomitant presence of brain, lung, bone metastases

Uncorrectable coagulation changes

Bleomycin allergy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: electrochemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 5 year

Secondary outcomes

1

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.

Time frame
through study completion, an average of 5 year
2

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.

Time frame
through study completion, an average of 5 year
3

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.

Time frame
through study completion, an average of 5 year
4

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.

Time frame
through study completion, an average of 5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Oncologico Veneto IRCCS

Lead sponsor

IGEA

Collaborator

Source ClinicalTrials.gov
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