Comparing idarubicin and doxorubicin for liver cancer treatment

Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma (IDADOX)

This study is testing whether idarubicin works as well as doxorubicin for treating liver cancer in patients receiving a specific type of chemotherapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Drugs / interventions: chemotherapy, doxorubicin
• Locations: 1 site (Seoul)
• Trial ID: NCT06114082 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of idarubicin compared to doxorubicin in patients with hepatocellular carcinoma undergoing transarterial chemoembolization (TACE). Eligible participants will be randomly assigned to receive either idarubicin or doxorubicin as part of their treatment regimen. The study will assess the non-inferiority of idarubicin in terms of treatment outcomes, with follow-up evaluations at 1, 3, and 6 months post-treatment. The trial will also consider individual patient factors such as tumor size and vascularity when determining treatment specifics.

Who should consider this trial

Good fit: Ideal candidates include adults aged 19 or older with a diagnosis of hepatocellular carcinoma and specific tumor characteristics.

Not a fit: Patients with severe liver dysfunction or those who have previously received treatment for hepatocellular carcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with hepatocellular carcinoma.

How similar studies have performed: While doxorubicin is widely used, the comparative effectiveness of idarubicin in this context is less established, making this approach relatively novel.

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.).

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Principal investigator: Jin Woo Choi, MD, PhD — Seoul National University Hospital
• Study coordinator: Jin Woo Choi, MD, PhD

Conditions: Hepatocellular Carcinoma, Liver Cancer, Hepatocellular carcinoma, Transarterial chemoembolization, Doxorubicin, Idarubicin