Clinical trial NCT06753136: Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Visceral Tumors of Any Histotype
Visceral Lesions
Liver Cancer
Liver Metastasis Colon Cancer
Melanoma
Primary Pancreatic Tumor
Retroperitoneal Sarcoma
Abdominal and/or Peritoneal Localizations
Merkel Cell Carcinoma
Squamous Cell Carcinoma
Secondary Visceral Localizations of Any Histotype
Non-melanoma Skin Cancer
Keywords: electrochemotherapy
visceral lesions
Laparoscopic procedure
Laparotomic procedure
Percutaneous procedure
bleomycin
medical device
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
Collaborators: name: IGEA
First posted: 2024-12-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Primary objective and endpoint
timeFrame: through study completion, an average of 5 year
Secondary outcomes:
measure: Secondary objective and endpoints
timeFrame: through study completion, an average of 5 year
measure: Secondary objective and endpoints
timeFrame: through study completion, an average of 5 year
measure: Secondary objective and endpoints
timeFrame: through study completion, an average of 5 year
measure: Secondary objective and endpoints
timeFrame: through study completion, an average of 5 year
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
References: