Clinical trial NCT02291133 (phase 1/phase 2, status: completed)
Conditions: liver cancer
ICD codes: D13.4, Z85.05, C22.8, C78.7, C22.9, D37.6
Drugs: bleomycin phc 15 e. (united states pharmacopeia - usp)
SMILES: C[C@@H](O)[C@H](NC(=O)[C@@H](C)[C@H](O)[C@@H](C)NC(=O)[C@@H](NC(=O)C1=C(C)C(N)=NC(=N1)[C@H](CC(N)=O)NC[C@H](N)C(N)=O)[C@@H](OC1OC(CO)C(O)C(O)C1OC1OC(CO)C(O)C(OC(N)=O)C1O)C1=CN=CN1)C(=O)NCCC1=NC(=CS1)C1=NC(=CS1)C(=O)NCCC[S+](C)C
Eligibility 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.