Clinical trial · Interventional
Treatment of Liver Metastases With Electrochemotherapy
- 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)
The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of liver metastases of colorectal cancer in clinical study phase I and II. The study will include 10-15 patients with colorectal cancer with synchronous or metachronous liver metastases, but electrochemotherapy will be performed on metastasis not more than 3 cm in the largest diameter. Treatment effectiveness will be evaluated by magnetic resonance imaging (MRI) and ultrasonography (US) in a monthly interval. Two or three month after the first operation the treated and untreated metastases will be resected and through histological analyses performed. The secondary objectives of the trial are to quantify the impact of the treatment on the patient's quality of life, tolerance to the therapy and suitability for larger study to be conducted.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrochemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of Toxicity Related to Electrochemotherapy (Toxicity, Symptoms)
- timeFrame
- After operation on day 7
Secondary outcomes (2)
- measure
- Number of Participants With Non-Serious Adverse Events
- timeFrame
- After operation on tha days 2, 7, 30, monthly
- measure
- Treatment Evaluation of Tumor Response - Measurements of Tumor Lesions by Contrast Enhanced Ultrasonography (US-Doppler), Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Histology
- timeFrame
- After operation or 1st day after operation, 7th day, 30th day, monthly
- description
- Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with measurable liver metastases, presented simultaneously with primary tumor, aimed at primary tumor resection and in a 2-3 month interval resection of liver metastases. One metastasis will be treated by electrochemotherapy, not larger than 3 cm in diameter. * Metastasis has to be accessible for application of electrochemotherapy during the operation, without major liver manipulation or mobilization in order not to create situation that would hamper feasibility of the second operation; resection of metastases. * Patients with metachronous liver metastases, that are positioned in unresectable liver area, near blood vessels, but inoperable patients. * Recurrent liver metastases, not more than 3, that are not larger than 3 cm in diameter. * Histologically and cytologically confirmed cancer, any histological differentiation. * Life expectancy more than 3 month. * Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≥ 2. * Age more than 18. * The patient must be offered standard treatment. * Electrochemotherapy is offered to the patients in the case of the disease progression during the standard treatment, in the case or metastases recurrence, or when they refuse standard treatment. * Treatment free interval 2-5 weeks, depending on the drugs used. * Patient must be mentally capable of understanding the information given. * Patient must give informed consent. Exclusion Criteria: * Metastases more than 3 cm in diameter. * Synchronous unresectable metastases. * Metachronous unresectable metastases or bigger than 3 cm in diameter. * Visceral, bone or diffuse metastases. * Coagulation disturbances. * Allergic reaction to bleomycin, or cumulative dose of 250 mg/m2 bleomycin received. * Impaired kidney function (creatinin \> 150 µmol/l). * Patients with hearth failure or pace maker. * Patients with epilepsy. * Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma. * Pregnancy.
References
Publications (1)
- DERIVEDEdhemovic I, Gadzijev EM, Brecelj E, Miklavcic D, Kos B, Zupanic A, Mali B, Jarm T, Pavliha D, Marcan M, Gasljevic G, Gorjup V, Music M, Vavpotic TP, Cemazar M, Snoj M, Sersa G. Electrochemotherapy: a new technological approach in treatment of metastases in the liver. Technol Cancer Res Treat. 2011 Oct;10(5):475-85. doi: 10.7785/tcrt.2012.500224. PMID 21895032