AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2IDADOXNCT06114082

TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma

A Phase 2 study testing IDA-TACE and DOX-TACE in people with Hepatocellular Carcinoma and Liver Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hepatocellular Carcinoma, Liver Cancer
What is being tested?
IDA-TACE and DOX-TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteSouth Korea
Study dates
28 Jul 2023to 1 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma (IDADOX)

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.

Read the 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 chemoembolization using a microcatheter and chemoemulsion. For the chemoemulsion preparation method, 10 mg of idarubicin powder (IDA-cTACE) or 50 mg of doxorubicin powder (DOX-cTACE) will be dissolved by 2.5 mL of iodinated contrast media, and then mixed with 10 mL of iodized poppy seed oil (Lipiodol; Lipiodol Ultrafluid, Guerbet, France). The amount of chemoemulsion administered to each patient will be determined by an operator regarding tumor size, vascularity, etc. Additional embolization will be performed using calibrated gelatin sponge particles usually 100-350 µm until the arterial flow is almost stopped. Afterwards, Patients will be evaluated at 1, 3, and 6 months after the initial treatment, but the follow-up can be individualized at the discretion of hepatologists or hepatic surgeons blinded to the treatment allocation. In cases of residual or recurred tumor, additional treatments will be determined by the blinded hepatologists or hepatic surgeons. Once a patient with residual or recurred tumor receives repetitive TACE, the same drug (idarubicin or doxorubicin) used at the initial TACE will be used for re-treatments.

Being tested
IDA-TACE, DOX-TACE
Keywords
Hepatocellular carcinoma, Transarterial chemoembolization, Doxorubicin, Idarubicin
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDA-TACEProcedure or surgery

    Also called Conventional TACE using idarubicin chemoemulsion

    Stable chemoemulsion will be produced by dissolving 10 mg of idarubicin powder (Zavedos; Pfizer, New York, NY, USA) in 2.5 mL of an iodinated contrast agent. This solution will then be mixed with 10 mL of iodized oil (Lipiodol Ultrafluid; Guerbet, Villepinte, France) using a three-way stopcock. This chemoemulsion will be prepared in aliquots (0.8 mL of chemoemulsion in each 1 mL syringe) and injected until the embolization endpoint is achieved.

  • DOX-TACEProcedure or surgery

    Also called Conventional TACE using doxorubicin chemoemulsion

    Stable chemoemulsion will be produced by dissolving 50 mg of doxorubicin powder (Adriamycin RDF; Ildong Pharmaceutical, Seoul, Republic of Korea) in 2.5 mL of an iodinated contrast agent. This solution will then be mixed with 10 mL of iodized oil (Lipiodol Ultrafluid; Guerbet, Villepinte, France) using a three-way stopcock. This chemoemulsion will be prepared in aliquots (0.8 mL of chemoemulsion in each 1 mL syringe) and injected until the embolization endpoint is achieved.

Study groups in NCT06114082
Study groupRoleWhat they receive
IDA-TACEExperimentalPatients treated by conventional TACE using idarubicin chemoemulsion
Receives: Procedure: IDA-TACE
DOX-TACEActive comparatorPatients treated by conventional TACE using doxorubicin chemoemulsion
Receives: Procedure: DOX-TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    the number of patients with partial or complete response as the best overall response divided by the total number of participants in the analysis population

    Measured: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

Secondary outcomes (9)

  1. 3-month tumor response by LI-RADS tumor response criteria

    Measured: From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

  2. 3-month tumor response by localized mRECIST

    Measured: From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

  3. 3-month tumor response by mRECIST

    Measured: From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

  4. 6-month tumor response by LI-RADS tumor response criteria

    Measured: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

  5. 6-month tumor response by localized mRECIST

    Measured: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

  6. 6-month tumor response by mRECIST

    Measured: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

  7. Time-to-progression

    Time interval between the first TACE to tumor progression by mRECIST

    Measured: From the date of randomization to tumor progression or study termination (6 months after the last patient is treated), whichever comes first

  8. Adverse event

    Common Terminology Criteria for Adverse Events v5.0

    Measured: 30 days

  9. Treatment-related serious adverse event

    Common Terminology Criteria for Adverse Events v5.0

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start28 Jul 2023
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06114082
Sponsor's protocol ID
H-2211-153-1381
Acronym
IDADOX
Status last verified
Aug 2026
First submitted
19 Oct 2023
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Choi JW, Kim HC, Han J, Jang MJ, Chung JW. Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma (IDADOX): Protocol for a Randomized, Non-inferiority, Double-Blind Trial. Cardiovasc Intervent Radiol. 2024 Mar;47(3):372-378. doi: 10.1007/s00270-023-03621-9. Epub 2023 Dec 26.

    PubMed 38147153

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IDA-TACE and DOX-TACE in people with Hepatocellular Carcinoma and Liver Cancer, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06114082, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in