Treatment of Primary Liver Tumors With Electrochemotherapy (ECT)

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate toxicity and effectiveness of electrochemotherapy with bleomycin in treatment of primary liver tumors in clinical study phase I and II.

The study will include 10 patients in phase I clinical study and additional 15 patients in phase II clinical study (or in the extension of the clinical study), which will fulfill inclusion criteria.

Treatment effectiveness will be evaluated by DCE-US or CT perfusion, to detect early events in tumor perfusion after ECT compared to tumor perfusion before ECT. Long term effectiveness of the treatment will be evaluated by modified RECIST criteria, which will take into account difference in size and density, determined from images obtained by CT perfusion of the treated tumor nodules before and after ECT. Tumor volume will be calculated by following formula , where a will be shorter and b longer tumor diameter.

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masa Bosnjak; University Medical Centre Ljubljana
• Collaborators: Institute of Oncology Ljubljana; University of Ljubljana
• Treatments: Bleomycin

Criteria

Inclusion Criteria:

1. Patients with primary liver tumors; hepatocellular carcinoma, intrahepatic cholangiocarcinoma and other primary tumors not larger than 7 cm that are positioned in unresectable liver area, near blood vessels in operable patients.

2. Patients with the progression of the disease (confirmed by radiological imaging) after treatment with TACE, RFA or percutaneous alcohol ablation, which are not suitable for potentially curative treatment, but with relatively good "performance status" and Child-Pugh score < 8.

Patients from group 1. and 2. are patients, in whom standard treatment procedures are not eligible, so ECT will be the only therapeutic option. In patients with multiple liver tumors, unresectable tumors which are also unsuitable for RAF will be treated by ECT, whereas other tumors will be resected or treated by RAF.

3. Patients with tumors smaller tumors, not suitable for liver transplantation, but also unsuitable for RFA treatment or percutaneous alcohol ablation because of the position of the tumor. Electrochemotherapy will be as bridge therapy, till liver transplantation.

4. Patients with tumors> 4 cm in diameter, in difficult to reach locations, and patients unsuitable for treatment with other treatment options.

Patients from group 3. and 4. are patients, potentially curable with standard treatment. Electrochemotherapy in these patients will not affect the standard of care of these patients, recommended in guidelines for HCC.

5. Electrochemotherapy is offered to the patients also when they refuse standard treatments.

6. Histologically confirmed primary liver cancer and/or based on radiological imaging laboratory tests confirmed primary liver cancer by multidisciplinary team for liver tumors.

7. Age more than 18.

8. Life expectancy more than 3 month.

9. Performance status Karnofsky ≥ 70 or (World Health Organization) WHO < or 2.

10. Treatment free interval 2-5 weeks, depending on the drugs used.

11. Patient must be mentally capable of understanding the information given.

12. Patient must give informed consent.

13. Patient must be discussed at the multidisciplinary team for liver tumors 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 (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).

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 heart failure or pace maker.

14. Pregnancy.

15. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.