TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma

NCT06114082 | Recruiting Phase 2 DMC

• 1 other identifier: H-2211-153-1381
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Cancer

Keywords

Hepatocellular carcinoma; Transarterial chemoembolization; Doxorubicin; Idarubicin

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  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 Outcomes (9)

• 3-month tumor response by LI-RADS tumor response criteria

  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

  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

  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

  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

  From the initial TACE to the end of the 6-month follow-up or commencement of subsequent anticancer treatment, whichever comes first

Study Arms (2)

IDA-TACE

EXPERIMENTAL

Patients treated by conventional TACE using idarubicin chemoemulsion

Procedure: IDA-TACE

DOX-TACE

ACTIVE COMPARATOR

Patients treated by conventional TACE using doxorubicin chemoemulsion

Procedure: DOX-TACE

Interventions

IDA-TACE PROCEDURE

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.

Also known as: Conventional TACE using idarubicin chemoemulsion

IDA-TACE

DOX-TACE PROCEDURE

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.

Also known as: Conventional TACE using doxorubicin chemoemulsion

DOX-TACE

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with HCC involving the portal vein or hepatic vein.
• Patients with extrahepatic spread of HCC
• Patients diagnosed with a cancer other than HCC within 2 years of enrollment.
• Patients who have undergone a biliary-intestinal anastomosis.
• 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.).

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Guerbet: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Related Publications (1)

• Choi JW, Kim HC, Han J, Jang MJ, Chung JW. 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. 2024 Mar;47(3):372-378. doi: 10.1007/s00270-023-03621-9. Epub 2023 Dec 26.

  PMID: 38147153 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jin Woo Choi, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Woo Choi, MD, PhD

CONTACT

82-2-2072-4334; jwchoi.med@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: November 2, 2023
• Study Start: April 28, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)