NCT06114082 TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma
| NCT ID | NCT06114082 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seoul National University Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-04-28 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 128 participants in total. It began in 2023-04-28 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria: 1. Patients with HCC involving the portal vein or hepatic vein. 2. Patients with extrahepatic spread of HCC 3. Patients diagnosed with a cancer other than HCC within 2 years of enrollment. 4. Patients who have undergone a biliary-intestinal anastomosis. 5. 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.).
Contact & Investigator
Jin Woo Choi, MD, PhD
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT06114082 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06114082 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06114082 currently recruiting?
Yes, NCT06114082 is actively recruiting participants. Contact the research team at jwchoi.med@snu.ac.kr for enrollment information.
Where is the NCT06114082 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06114082 clinical trial?
NCT06114082 is sponsored by Seoul National University Hospital. The principal investigator is Jin Woo Choi, MD, PhD at Seoul National University Hospital. The trial plans to enroll 128 participants.
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