Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
About this study
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.
- Condition
- 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
- Tested
- percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
- Sponsor
- Istituto Oncologico Veneto IRCCS
Who can join
- Age
- 18 to 99 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 99 years
- Study condition: 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
- 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 8
- 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
Where
1 site, 1 recruiting
Istituto Oncologico Veneto
Padova, Italy
Contact
-
Francesco Russano, MD
049 8211693 francesco.russano@iov.veneto.it
Potential match only. Final eligibility is determined by the study team.