Clinical trial · Interventional
Electrochemotherapy (ECT) in Patients With Primary Visceral Tumors and/or Secondary Visceral Localizations, of Any Histotype
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal and/or Peritoneal Localizations | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| Primary Pancreatic Tumor | — | UNRESOLVED | — |
| Primary Visceral Tumors of Any Histotype | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| percutaneous, laparoscopic or laparotomy lesion electrochemotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- electrochemotherapy
- description
- Patients who meet the inclusion criteria will undergo percutaneous, laparoscopic or laparotomy lesion electrochemotherapy within 30 days from the time of obtaining informed consent for study participation (T0), during pre-surgery visit.The ECT will be performed in accordance with the Standard Operating Procedures (SOPs).During the first month after treatment, the patient's response will be assessed every 2 weeks, and thereafter, once a month for a total of 12 months.
- interventionNames
- Device: percutaneous, laparoscopic or laparotomy lesion electrochemotherapy
Primary outcomes (1)
- measure
- Primary objective and endpoint
- timeFrame
- through study completion, an average of 5 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available