Clinical trial · Interventional
Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
- 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 study is prospective, phase II study, The primary objective of the study is evaluation of the feasibility and safety of intraoperative electrochemotherapy of colorectal liver metastases. The secondary objective is to determine the efficacy of electrochemotherapy treatment, based on histological and radiological evaluation of treated metastases. The endpoints are: toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0 and response rate measured by percentage of vital tumor cells and mRECIST criteria.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bleomycin PHC 15 e. (United States Pharmacopeia - USP) | Drug | — | UNRESOLVED |
| Cliniporator Vitae® | Device | — | UNRESOLVED |
| Electrochemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Electrochemotherapy
- interventionNames
- Procedure: Electrochemotherapy
- Device: Cliniporator Vitae®
- Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP)
Primary outcomes (1)
- measure
- Evaluation of Safety Related to Electrochemotherapy
- timeFrame
- After operation on day 7
- description
- Recording of adverse events according to CTCAE criteria
Secondary outcomes (1)
- measure
- Response to Treatment (Determined by Modified RECIST Criteria).
- timeFrame
- After operation on the days 30, 60, 90 and 120
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically and/or cytologically confirmed colorectal cancer. 2. Age over 18. 3. Life expectancy more than 3 month. 4. Performance status Karnofsky ≥ 70 or (World Health Organization) WHO ≤ 2. 5. Chemotherapy free interval 2-5 weeks, depending on the drugs used. 6. Patient must be mentally capable of understanding the information given. 7. Patient must give informed consent. 8. Patient must be discussed at the multidisciplinary team for tumors of the gastrointestinal tract before entering the trial. Exclusion Criteria: 1. Secondary primary tumor, except surgically treated noninvasive cancer of cervix, or surgically or irradiated basal cell carcinoma 2. Visceral, bone or diffuse metastases. 3. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies. 4. Clinically significant ascites. 5. Significant reduction in respiratory function. 6. Age less than 18 years. 7. Coagulation disturbances. 8. Cumulative dose of 250 mg/m2 bleomycin received. 9. Allergic reaction to bleomycin. 10. Impaired kidney function (creatinin \> 150 µmol/l). 11. Patients with epilepsy. 12. Patients with arrhythmias. 13. Patients with pacemaker or defibrillator. 14. Pregnancy. 15. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
References
Publications (2)
- BACKGROUNDEdhemovic I, Brecelj E, Gasljevic G, Marolt Music M, Gorjup V, Mali B, Jarm T, Kos B, Pavliha D, Grcar Kuzmanov B, Cemazar M, Snoj M, Miklavcic D, Gadzijev EM, Sersa G. Intraoperative electrochemotherapy of colorectal liver metastases. J Surg Oncol. 2014 Sep;110(3):320-7. doi: 10.1002/jso.23625. Epub 2014 Apr 30. PMID 24782355
- BACKGROUNDEdhemovic 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