RecruitingPhase 2NCT06114082

TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma

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


Sponsor

Seoul National University Hospital

Enrollment

128 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy drugs — idarubicin and doxorubicin — used in a procedure called TACE (transarterial chemoembolization), which delivers chemotherapy directly to liver tumors while cutting off their blood supply. Researchers want to see which drug works better for liver cancer. **You may be eligible if:** - You are 19 or older - You have been diagnosed with hepatocellular carcinoma (HCC), the most common type of liver cancer - You have 5 or fewer tumors, with the largest being 5 cm or smaller - You have not previously been treated for HCC - Your liver is still functioning reasonably well (Child-Pugh class A or B) - Your overall health is reasonably good (ECOG 0-2) **You may NOT be eligible if:** - You have already received treatment for liver cancer - You have more than 5 tumors or a tumor larger than 5 cm - You have severe liver, kidney, or heart problems - You have cancer that has spread outside the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIDA-TACE

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.

PROCEDUREDOX-TACE

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.


Locations(1)

Seoul National University Hospital

Seoul, South Korea

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NCT06114082


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