Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma (IDADOX): Protocol for a Randomized, Non-inferiority, Double-Blind Trial

This study aims to test the hypothesis that idarubicin-based transarterial chemoembolization (IDA-TACE), using one of the most potent chemotherapeutic agents, could yield oncologic outcomes equivalent to or marginally improved over doxorubicin-based TACE (DOX-TACE).Materials and MethodsThis single-center, prospective, phase II, randomized controlled, non-inferiority, double-blind trial will enroll 128 treatment-na ïve patients with HCC (≤ 5 tumors, 1–5 cm in diameter) for conventional TACE. Participants will be randomly assigned (1:1) to either IDA-TACE or DOX-TACE, with stratification by Child–Pugh class. Superselective conventional TACE will be performed using cone-beam CT and small-bore microcath eters. Patient evaluations, including dynamic imaging and blood tests, will occur at 1, 3, and 6 months post-initial treatment. The primary outcome measure is the objective response rate (ORR) according to mRECIST at 6 months. Secondary outcomes include 3-month and 6-month tumor responses, time-to -progression, the incidence of treatment-related serious adverse events within 30 days, and the incidence and severity of any adverse events.StatisticsNon-inferiority will be claimed if the upper limit of a one-sided 97.5% confidence interval for the proportion difference (i.e.,"6-month ORR of DOX-TACE"  − "6-month ORR of IDA-TACE") falls below 0.15 in both intention-to-treat and per-protocol analyses. The proportion difference and its confidence in...
Source: CardioVascular and Interventional Radiology - Category: Radiology Source Type: research