NCT06114082CompletedPhase 2
TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma
Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma (IDADOX)
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 19 Oct 2023
- Start date
- 28 Jul 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06114082
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 128
- From 28 Jul 2023 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients diagnosed with a cancer other than HCC within 2 years of enrollment.
- 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.).
Other
- Patients with HCC involving the portal vein or hepatic vein.
- Patients with extrahepatic spread of HCC
- Patients who have undergone a biliary-intestinal anastomosis.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.