Hepatocelullar caricinoma Hepatocellular carcinoma
Conditions
Interventions
Irreversible electroporation
Sponsors
Takeuchi Hirohito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male and female with older than or equal to 20-year-old 2)Patients who are pathologically proven or radiologically diagnosed hepatocellular carcinoma (HCC) 3)Patients with HCC who meet Milan criteria (one lesion smaller than 5 cm; alternatively, up to 3 lesions, each smaller than 3 cm) 4)Patients who are not eligible for liver resection and radiofrequency ablation 5)Presence or absence of pretreatment is not essential qualification; but it is necessary that at least more than 4 weeks has passed since previous treatment 6)Patients with Child-Pugh score less than or equal to 9 7)Patients with ECOG performance status of 0 to 2 8)Patients preserved adequate bone morrow, liver and kidney functions, as shown below: White blood cell: >2,000 /mm3, and/or 50,000 /mm3 Hemoglobin: >8.0 g/dL Serum total bilirubin: 45 ml/min/1.73m2 BUN: <35 mg/dL 9)Patients who have obtained agreements for participation in writing
Exclusion criteria
Exclusion criteria: 1)Patients who have active double cancer (synchronous double cancer) or who have metachronous double cancer within five years disease duration: note that carcinoma in situ which is judged to be cure is not included 2)Patient who have diagnosed as myocardial infarction, unstable angina, cardiac failure, and arrhythmia with care within 6 months before registration 3)Patients who are difficult to be secured of safety percutaneous approach 4)Patients who use pacemakers 5)Patients who have iodine allergies, decline in renal function (eGFR<45ml/min/1.73m2), and cannot undertake contrast-enhanced CT for any reasons 6)Patients who are judged to be difficult to undergo this clinical trial due to psychiatric disease or psychological symptom 7)Patients who are in pregnancy or probable of pregnancy 8)Besides, patients who are judged as inappropriate for registration by doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR) rate after 12-month from treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time, Recurrent-free survival time, Posttreatment 1-, 2-,3-year liver function, Recurrent pattern, Liver function at recurrent time, Severe adverse events rate | — |
Contacts
Public ContactHIrohito Takeuchi
Tokyo Medical University
Outcome results
None listed