Abdominal and/or Peritoneal Localizations, Liver Cancer, Liver Metastasis Colon Cancer, Melanoma, Merkel Cell Carcinoma, Non-melanoma Skin Cancer, Primary Pancreatic Tumor, Primary Visceral Tumors of Any Histotype, Retroperitoneal Sarcoma, Secondary Visceral Localizations of Any Histotype, Squamous Cell Carcinoma, Visceral Lesions
Conditions
Keywords
electrochemotherapy, visceral lesions, Laparoscopic procedure, Laparotomic procedure, Percutaneous procedure, bleomycin, medical device
Brief 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.
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
DEVICEpercutaneous, 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.
Sponsors
Istituto Oncologico Veneto IRCCS
IGEA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary objective and endpoints | 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. |
Countries
Italy
Contacts
CONTACTFrancesco Russano, MD
Outcome results
None listed