Status:
RECRUITING
TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Guerbet
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 co...
Detailed Description
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 conventional chemo...
Eligibility Criteria
Inclusion
- Adults aged 19 or above.
- Patients diagnosed with HCC either histologically and/or radiologically (LI-RADS 4 or 5).
- Patients with five or fewer tumors.
- Patients in which the largest tumor is 5 cm or less in diameter.
- Patients with no prior treatment experience for HCC.
- Patients categorized as Child-Pugh class A or B.
- Patients with an Eastern Cooperative Oncology Group performance status of 2 or below.
- 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 realistically impossible or, even if technically possible, do not have significant clinical benefits compared to TACE.
- Patients who have understood sufficiently about this clinical trial and have given written consent to participate.
- Fertile women capable of effective contraception for at least 6.5 months after TACE, and men with fertile female partners capable of effective contraception for at least 3.5 months after TACE.
Exclusion
- Patients with HCC involving the portal vein or hepatic vein.
- Patients with extrahepatic spread of HCC
- Patients diagnosed with a cancer other than HCC within 2 years of enrollment.
- Patients who have undergone a biliary-intestinal anastomosis.
- Patients for whom the use of idarubicin or doxorubicin is contraindicated (including severe heart failure, arrhythmia, hypersensitivity to anthracycline chemotherapy, pregnant or nursing women, etc.).
Key Trial Info
Start Date :
April 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06114082
Start Date
April 28 2023
End Date
June 30 2026
Last Update
January 7 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080