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Spots Global Cancer Trial Database for TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma (IDADOX)

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Trial Identification

Brief Title: TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients With Hepatocellular Carcinoma (IDADOX)

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

Study ID: NCT06114082

Interventions

IDA-TACE
DOX-TACE

Study Description

Brief 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.

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.

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Seoul National University Hospital, Seoul, , Korea, Republic of

Contact Details

Name: Jin Woo Choi, MD, PhD

Affiliation: Seoul National University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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