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

What this Trial Is About

Researchers are comparing two chemotherapy drugs, idarubicin and doxorubicin, to see if idarubicin is not less effective than doxorubicin for treating hepatocellular carcinoma, a type of liver cancer. This Phase 2 randomized controlled trial aims to evaluate if the choice of chemotherapeutic agent affects the success of transarterial chemoembolization (TACE) in patients receiving this treatment as their first line. The study addresses the uncertainty about whether different drugs impact treatment outcomes, noting that while doxorubicin is commonly used, idarubicin has shown promising results in early studies. Participants are randomly assigned to receive TACE with either idarubicin or doxorubicin chemoemulsion. The chemoemulsion is prepared by dissolving the drug powder in an iodinated contrast agent and mixing it with iodized oil. The amount given is based on tumor characteristics, and additional embolization is done to reduce blood flow. Follow-up assessments occur at 1, 3, and 6 months, with further treatments using the same initial drug if tumors persist or recur. Throughout the study, patients undergo evaluations including imaging and clinical exams to monitor tumor response and safety. The main outcome measured is the objective response rate from the initial treatment until 6 months or the start of other anticancer therapies. Safety is monitored by specialists who are unaware of the assigned treatment. Participation includes careful follow-up to assess effectiveness and guide any additional treatments needed, with the total study period covering at least six months after initial therapy.

TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma