Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II
Condition: Liver Metastases
MeSH terms: Neoplasm Metastasis; Liver Neoplasms
Intervention: Electrochemotherapy; Cliniporator Vitae®; Bleomycin PHC 15 e. (United States Pharmacopeia - USP)
Intervention description: Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin, within 8-30 min after administration of bleomycin application of electric pulses, removal of electrodes.; Positioning of electrodes, within 8-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.; Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses
Intervention MeSH terms: Bleomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver metastases of colorectal cancer Electrochemotherapy; Bleomycin; Electrochemotherapy

Summary:

      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.
    

Eligibility criteria:

        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.