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JRCT ID: jRCTs052200095

Registered date:15/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma
• Date of first enrollment: 20/01/2021
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Injection of lipiodol / epirubicin emulsion formed by using the devise

Outcome(s)

• Primary Outcome: local complete response rate of treated lesion by selective TACE using an emulsification devise at 3 months after TACE
• Secondary Outcome: local complete response rate of treated lesion at 1 month after TACE, Adverse events, serious adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Histologically or clinically diagnosed hepatocellular carcinoma
2. No indication for surgical resection, liver transplantation, or local ablation therapy
3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection and possible to perform selective cTACE
4. No previous treatment for HCC nodules in which TACE is planned
5. Measurable HCC nodules in which TACE is planned
6. Maximum HCC nodule of 5cm or less in which TACE is planned
7. ECOG Performance Status 0-1
8. Child-Pugh A or B
9. Adequate organ function
a. T-Bil<=3.0 mg/dL
b. AST/ALT within 5 times of upper normal limit or 250 IU/L
10. Age of 20 years or over
11. Written informed consent

Exclude criteria

1.Tumor thrombosis in portal vein
2. Extrahepatic metastasis
3. Ruptured HCC nodules in which TACE is planned
4. Extrahepatic feeding arteries for HCC nodules in which TACE is planned
5. Prior surgical reconstruction or endoscopic treatment of the biliary tract
6. Clinically significant refractory ascites or pleural effusion
7. Severe arterio-portal or arterio-venous shunts in the liver
8. Allergy to contrast medium that precludes angiography
9. Previously registered patients in this study
10. Severe, active co-morbidity
a.Uncontrolled heart failure, angina or dysrhythmia
b.Myocardial infarction within 6 months
c.Renal failure (dialysis or eGFR<30)
d.Active infectious disease (except of viral hepatitis)
e.Active gastrointestinal bleeding
f.Another malignant disease with necessity of treatments
g.Hepatic coma or severe mental disturbance

11. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception
12. Not eligible because of safety issues judged by investigators

Related Information

• Primary Sponsor: Tanaka Toshihiro
• Source(s) of Monetary Support: PIOLAX MEDICAL DEVICES, INC.