Hepatocellular carcinoma
Conditions
Interventions
Adjuvant
Sponsors
Kanazawa university
Kasumigaura Hospital Tokyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient selection Hepatocellular carcinoma patients with multiple nodules in liver or with distant metastasis, which are inadequate to curative treatment and refractory for chemotherapy using antitumor drugs (more than 2 cycles).The patients with preserved liver function (liver damage A or B in 4th criteria Liver Cancer Study Group of Japan) and more than 2 months estimated survival period. The patients should be able to performance radiofrequency ablation therapy. (following: the patients called with RFA+ISAIA cases) Inclusion criteria 1. Histologically- or radiologically- proven hepatocellular carcinoma with multiple intrahepatic nodules or distant metastasis 2. At lease single nodules which measurable by imaging study 3. Not adequate to curative treatment 4. Refractory for chemotherapy using antitumor drugs (more than 2 cycles)(RECIST criteria SD,PD) 5. No vascular invasion (portal vein, bile duct hepatic vein) 6. More than 2 months estimated survival period 7. Possible to radiofrequency ablation therapy 8. Preserved liver function (liver damage A or B in 4th criteria Liver Cancer Study Group of Japan) 9. Preserved bone marrow function after chemotherapy (WBC >3000/uL, Lymphocyte >1000/uL, Hb >8.5g/dL, Platelet>50000/uL at the point of more than 4 weeks after chemotherapy) 10. Normal renal function (serum Cr less than 1.5 mg/dL) 11. Karnofsky Perfomance Scale (KPS) more than 60% or ECOG Performance status 0 or 1 12. More than 18 years old, less than 90 years old 13. Informed about the cancer and the severity, get adequate informed consent 14. Possible to treatment and follow up in our hospital 10. Normal renal function (serum Cr less than 1.5 mg/dL) 11. Karnofsky Perfomance Scale (KPS) more than 60% or ECOG Performance status 0 or 1 12. More than 18 years old, less than 90 years old 13. Informed about the cancer and the severity, get adequate informed consent 14. Possible to treatment and follow up in our hospital
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) Past history of other caner except hepatocellular carcinoma in recent 5 year, or present affecting cancer 2) Past history of autoimmune disease or present affecting autoimmune disease 3) Infected HIV 4) Technically difficult main tumor for radiofrequency ablation 5) Difficult for this treatment because of hematological disease or bleeding tendency 6) Uncontrolled diseases such as sever infectious disease, severe cardiac disease and psychological diseases 7) (1) Systemic administration of anti-cancer drugs or steroid, (2) Radiological or biological treatment which may affect to systemic condition, within 4 weeks before this treatment 8) Pregnant or nursing woman or person who has the possibility of pregnancy and plan to pregnant 9)Affecting tuberculosis, or more than 2 cm in diameter induration reaction positive after skin reaction test using immune adjuvant specially made in our hospital 10) inadequate cases by principle doctor including uncertainty to adherent to treatment protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Outcome results
None listed