Transarterial Chemoembolization using Idarubicin versus Doxorubicin Chemoemulsion in Patients with Hepatocellular Carcinoma (IDADOX)

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0008166
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

a.Age > 18 years
b.Histologically or radiologically (LI-RADS 4 or 5) diagnosed as hepatocellular carcinoma
c.Tumor number = 5
d.Largest tumor diameter = 5 cm
e.Treatment-naïve patient
f.Child-Pugh class A or B
g.Eastern Cooperative Oncology Group performance status = 2
h.No severe impairment of major organs (Blood tests performed within one month of the procedure must satisfy all of the following findings)
- 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
i.Patients for whom conventional transarterial chemoembolization was determined as the optimal treatment after hepatologists', hepatic surgeons' or multidisciplinary clinics.
j.Patients who fully understand and agree to participate in this clinical trial in writing
k.Patients with effective contraception for at least 6.5 months post-treatment for women with childbearing age, and 3.5 months post-treatment for men with partners with childbearing age

Exclusion Criteria

a.Hepatocellular carcinoma with vascular invasion
b.Hepatocellular carcinoma with extrahepatic spread
c.Patients with active cancer other than hepatocellular carcinoma within 2 years from the enrollment
d.Patients with previous biloenteric anastomosis surgery.
e.Patients contraindicated to the use of idarubicin or doxorubicin

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
objective response rate (mRECIST)

Secondary Outcome Measures

Name	Time	Method
Tumor response rate (LI-RADS v2018, treatment response);Treatment-related serious adverse event;Incidence and severity of adverse event