Could a new drug match the standard for liver cancer treatment?
NCT ID NCT06114082
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial is testing whether a chemotherapy drug called idarubicin works as well as the standard drug doxorubicin when used in a procedure called transarterial chemoembolization (TACE) for liver cancer. TACE delivers chemotherapy directly to the tumor and blocks its blood supply. The study will include adults with hepatocellular carcinoma who have not had prior treatment. The goal is to see if idarubicin is not inferior to doxorubicin in shrinking or controlling tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- idarubicin
- What this could lead to
- If idarubicin proves as effective as doxorubicin, it could offer an alternative chemoembolization option for liver cancer patients, potentially with different side effects or benefits.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The study may not show a significant difference, or idarubicin could have unforeseen side effects. Non-inferiority trials also have specific statistical limitations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
128 people
The number who actually took part.
- Started
-
Jul 2023
- Finished
-
Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Seoul National University Hospital
Seoul, 03080, South Korea
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