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Efficacy of Irreversible electroporation (IRE) on patients with hepatocellular carcinoma who are not eligible for liver resection and radiofrequency ablation (RFA): a multicenter trial

Efficacy of IRE for patients with HCC

Takeuchi Hirohito

Tokyo Medical University

6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan

htake@tokyo-med.ac.jp

Takeuchi HIrohito

Tokyo Medical University

6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan

+81-3-3342-6111

htake@tokyo-med.ac.jp

Recruiting

Aug. 27, 2019

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

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 <10,000 /mm3
Platelet: >50,000 /mm3
Hemoglobin: >8.0 g/dL
Serum total bilirubin: <2.0 mg/dL
eGFR: >45 ml/min/1.73m2
BUN: <35 mg/dL
9) Patients who have obtained agreements for participation in writing

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

Both

Hepatocelullar caricinoma

Irreversible electroporation

Hepatocellular carcinoma

Irreversible electroporation

Complete response (CR) rate after 12-month from treatment

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

+81-3-3822-2131

July. 12, 2019

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