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

  • Study Protocol
  • Interventional Oncology
  • Published:
CardioVascular and Interventional Radiology Aims and scope Submit manuscript

Abstract

Purpose

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 Methods

This single-center, prospective, phase II, randomized controlled, non-inferiority, double-blind trial will enroll 128 treatment-naïve 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 microcatheters. 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.

Statistics

Non-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 interval will be calculated by the Cochran–Mantel–Haenszel method to obtain a weighted average of stratum-specific proportion differences.

Expected Gain of Knowledge

If IDA-TACE demonstrates outcomes comparable to DOX-TACE, this study could provide compelling evidence that various cytotoxic agents yield similar contributions in TACE, considering the minor role of chemotherapeutic agents in TACE.

Trial Registration

ClinicalTrials.gov (https://clinicaltrials.gov/). Identifier: NCT06114082. World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (https://trialsearch.who.int/Default.aspx). Identifier: KCT0008166.

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Acknowledgements

This study is funded by Guerbet (Grant Number: L.0141).

Funding

This study is funded by Guerbet (Grant Number: L.0141). Dr. Jin Woo Choi, the principal investigator of this study, wrote the protocol and the manuscript. The collection, analysis, and interpretation of data will take place at the clinical site. The funder of this study will not be involved in any steps of the study, including study design, data collection, data analysis or interpretation, or reviewing the manuscript.

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Authors and Affiliations

  1. Department of Radiology, Seoul National University Hospital, #101 Daehak-ro, Jongno-gu, Seoul, 03080, Korea

    Jin Woo Choi, Hyo-Cheol Kim & Jin Wook Chung

  2. Department of Radiology, Seoul National University College of Medicine, Seoul, Korea

    Jin Woo Choi, Hyo-Cheol Kim & Jin Wook Chung

  3. Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea

    Jiyeon Han & Myoung-jin Jang

Authors
  1. Jin Woo Choi
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  2. Hyo-Cheol Kim
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Corresponding author

Correspondence to Jin Woo Choi.

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Conflict of interest

Jin Woo Choi has received a research grant and a speaker honorarium from Guerbet. Hyo-Cheol Kim has received a speaker honorarium from Guerbet. Jin Wook Chung has received a speaker honorarium from Guerbet.

Ethical Approval

All procedures in this study will be in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed Consent

Informed consent will be obtained from all individual participants who will be included in the study.

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For this type of study, consent for publication is not required.

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Choi, J.W., Kim, HC., Han, J. et al. Transarterial Chemoembolization Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma (IDADOX): Protocol for a Randomized, Non-inferiority, Double-Blind Trial. Cardiovasc Intervent Radiol 47, 372–378 (2024). https://doi.org/10.1007/s00270-023-03621-9

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  • DOI: https://doi.org/10.1007/s00270-023-03621-9

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