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

October 27, 2023 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Jin Woo Choi, MD, PhD
        • Principal Investigator:
          • Jin Woo Choi, MD, PhD
        • Sub-Investigator:
          • Hyo-Cheol Kim, MD, PhD
        • Sub-Investigator:
          • Jin Wook Chung, MD, PhD
        • Sub-Investigator:
          • Do Hoon Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults aged 19 or above.
  2. Patients diagnosed with HCC either histologically and/or radiologically (LI-RADS 4 or 5).
  3. Patients with five or fewer tumors.
  4. Patients in which the largest tumor is 5 cm or less in diameter.
  5. Patients with no prior treatment experience for HCC.
  6. Patients categorized as Child-Pugh class A or B.
  7. Patients with an Eastern Cooperative Oncology Group performance status of 2 or below.

  8. Patients without severe functional abnormalities of major organs: the following results from a blood test conducted within a month prior to the procedure must be satisfied:

    • WBC count ≤ 12,000 / mm3
    • Absolute neutrophil count ≥ 1,500 /mm3
    • Hemoglobin ≥ 8.0 g/dL
    • Total bilirubin ≤ 3.0 mg/dL
    • eGFR ≥ 30 mL/min/1.73 m2
    • Patients deemed clinically most suitable to receive TACE through hepatologist, hepatic surgeon, or multidisciplinary consultation: patients for whom other treatments such as liver transplantation/surgery/ablation are realistically impossible or, even if technically possible, do not have significant clinical benefits compared to TACE.
    • Patients who have understood sufficiently about this clinical trial and have given written consent to participate.
    • Fertile women capable of effective contraception for at least 6.5 months after TACE, and men with fertile female partners capable of effective contraception for at least 3.5 months after TACE.

Exclusion Criteria:

  1. Patients with HCC involving the portal vein or hepatic vein.
  2. Patients with extrahepatic spread of HCC
  3. Patients diagnosed with a cancer other than HCC within 2 years of enrollment.
  4. Patients who have undergone a biliary-intestinal anastomosis.
  5. Patients for whom the use of idarubicin or doxorubicin is contraindicated (including severe heart failure, arrhythmia, hypersensitivity to anthracycline chemotherapy, pregnant or nursing women, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDA-TACE
Patients treated by conventional TACE using idarubicin chemoemulsion
Procedure: IDA-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.
Other Names:
  • Conventional TACE using idarubicin chemoemulsion
Active Comparator: DOX-TACE
Patients treated by conventional TACE using doxorubicin chemoemulsion
Procedure: DOX-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.
Other Names:
  • Conventional TACE using doxorubicin chemoemulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
the number of patients with partial or complete response as the best overall response divided by the total number of participants in the analysis population
From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-month tumor response by LI-RADS tumor response criteria
Time Frame: From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
3-month tumor response by localized mRECIST
Time Frame: From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
3-month tumor response by mRECIST
Time Frame: From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
From the initial TACE to the end of the 3-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
6-month tumor response by LI-RADS tumor response criteria
Time Frame: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
6-month tumor response by localized mRECIST
Time Frame: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
6-month tumor response by mRECIST
Time Frame: From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first
Time-to-progression
Time Frame: From the date of randomization to tumor progression or study termination (6 months after the last patient is treated), whichever comes first
Time interval between the first TACE to tumor progression by mRECIST
From the date of randomization to tumor progression or study termination (6 months after the last patient is treated), whichever comes first
Adverse event
Time Frame: 30 days
Common Terminology Criteria for Adverse Events v5.0
30 days
Treatment-related serious adverse event
Time Frame: 30 days
Common Terminology Criteria for Adverse Events v5.0
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Guerbet

Investigators

  • Principal Investigator: Jin Woo Choi, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2211-153-1381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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