Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT06114082

TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma

Led by Seoul National University Hospital · Updated on 2025-01-07

128

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

S

Seoul National University Hospital

Lead Sponsor

G

Guerbet

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

TACE Using Idarubicin Versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 or above
  • Diagnosis of hepatocellular carcinoma confirmed by histology or radiology (LI-RADS 4 or 5)
  • Five or fewer tumors present
  • Largest tumor size 5 cm or less in diameter
  • No previous treatment for hepatocellular carcinoma
  • Classified as Child-Pugh class A or B
  • Eastern Cooperative Oncology Group performance status of 2 or below
  • Blood test within one month before treatment showing: WBC count ≤ 12,000 / mm3, absolute neutrophil count ≥ 1,500 /mm3, hemoglobin ≥ 8.0 g/dL, total bilirubin ≤ 3.0 mg/dL, and eGFR ≥ 30 mL/min/1.73 m2
  • Clinically suitable for TACE as determined by hepatologist, hepatic surgeon, or multidisciplinary consultation
  • Provided informed written consent to participate
  • Fertile women able to use effective contraception for at least 6.5 months after TACE, and men with fertile female partners using effective contraception for at least 3.5 months after TACE
Not Eligible

You will not qualify if you...

  • Hepatocellular carcinoma involving the portal vein or hepatic vein
  • Presence of extrahepatic spread of hepatocellular carcinoma
  • Diagnosis of another cancer within 2 years before enrollment
  • History of biliary-intestinal anastomosis
  • Contraindications to idarubicin or doxorubicin, including severe heart failure, arrhythmia, hypersensitivity to anthracycline chemotherapy, pregnancy, or nursing

AI-Screening

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

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Research Team

J

Jin Woo Choi, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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