None listed
Conditions
Interventions
Drug : Eligible patients will be randomly allocated either in the IDA-cTACE or DOX-cTACE group, and the randomization can be stratified by Child-Pugh class. Each patient will be treated by conventiona
Lipiodol Ultrafluid, Guerbet, France). The amount of chemoemulsion administered to each patient will be determined by an operator regarding tumor size, vascularity, etc. Additional embolization will b
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Age > 18 years b. Histologically or radiologically (LI-RADS 4 or 5) diagnosed as hepatocellular carcinoma c. Tumor number = 5 d. Largest tumor diameter = 5 cm e. Treatment-naïve patient f. Child-Pugh class A or B g. Eastern Cooperative Oncology Group performance status = 2 h. No severe impairment of major organs (Blood tests performed within one month of the procedure must satisfy all of the following findings) - WBC count = 12,000 / mm3 - Absolute neutrophil count = 1,500 /mm3 - Hemoglobin = 8.0 g/dL - Total bilirubin = 3.0 mg/dL - eGFR = 30 mL/min/1.73 m2 i. Patients for whom conventional transarterial chemoembolization was determined as the optimal treatment after hepatologists', hepatic surgeons' or multidisciplinary clinics. j. Patients who fully understand and agree to participate in this clinical trial in writing k. Patients with effective contraception for at least 6.5 months post-treatment for women with childbearing age, and 3.5 months post-treatment for men with partners with childbearing age
Exclusion criteria
Exclusion criteria: a. Hepatocellular carcinoma with vascular invasion b. Hepatocellular carcinoma with extrahepatic spread c. Patients with active cancer other than hepatocellular carcinoma within 2 years from the enrollment d. Patients with previous biloenteric anastomosis surgery. e. Patients contraindicated to the use of idarubicin or doxorubicin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (mRECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate (LI-RADS v2018, treatment response);Treatment-related serious adverse event;Incidence and severity of adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactHyunhee Lee
Seoul National University Hospital
Outcome results
None listed