TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma
Trial Parameters
Brief Summary
Little is known about whether the types of chemotherapeutic agents affect the efficacy of transarterial chemoembolization in patients with hepatocellular carcinoma. Although doxorubicin is the most commonly-used chemotherapeutic agent in the world, idarubicin is recently in the spotlight after promising results of the in vitro and prospective single-arm studies. On the other hand, there are many reports showing that the type of chemotherapeutic agents does not significantly alter the efficacy of transarterial chemoembolization. This is a randomized-controlled trial to show the non-inferiority of idarubicin compared to doxorubicin in patients with hepatocellular carcinoma who receive transarterial chemoembolization as the first-line treatment.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 19 or above. 2. Patients diagnosed with HCC either histologically and/or radiologically (LI-RADS 4 or 5). 3. Patients with five or fewer tumors. 4. Patients in which the largest tumor is 5 cm or less in diameter. 5. Patients with no prior treatment experience for HCC. 6. Patients categorized as Child-Pugh class A or B. 7. Patients with an Eastern Cooperative Oncology Group performance status of 2 or below. 8. Patients without severe functional abnormalities of major organs: the following results from a blood test conducted within a month prior to the procedure must be satisfied: * 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 * Patients deemed clinically most suitable to receive TACE through hepatologist, hepatic surgeon, or multidisciplinary consultation: patients for whom other treatments such as liver transplantation/surgery/ablation are realistical