A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma

A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma - A randomized controlled trial for the comparison of radiofrequency ablation with and without transcatheter arterial chemoembolization for patients with hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002083

Enrollment

Registered

2009-06-18

Start date

2005-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

TACE-RFA group: Transcatheter arterial chemoembolization (TACE) was performed by selectively introducing a microcatheter into the right/left hepatic artery or tumor feeding arteries injecting epirubic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The HCC diagnoses were confirmed by histological or clinical confirmation (Bruix, et al. Hepatology 2005). 2) Any prior anti-cancer therapy for HCC is exclusionary. 3) Male or female subjects >=20 years old 4) Single HCC, > 3 cm in diameter. Percutaneous radiofrequency ablation can be performed technically under ultrasonic guidance. 5) Laboratory parameters: WBC < 12,000/mm3 Platelet >= 50,000/mm3 Hemoglobin >=9.5g/dL AST and ALT <= 5 x upper limit of normal Total bilirubin < 2.0mg/dL Serum creatinin <= upper limit of normal 6) Life expectancy of at least 3 months 7) Cirrhotic status of Child-Pugh class A or B, and ECOG performance status of 0-2 8) Voluntary signed and dated written informed consent from all the patients was obtained. 9) Radiological evidence of HCC showing lesion arterial hypervascularity by dynamic contrast-enhanced computed tomography or abdominal angiography 10) Transcatheter arterial embolization can be performed technically

Exclusion criteria

Exclusion criteria: 1) History of any other cancer curatively treated < 3years prior to study entry 2) Uncontrolled ascites or pleural effusion 3) Active clinically serious infection ( > grade 2 NCI) 4) Uncontrolled diabetes mellitus or ileus 5) Having with extrahepatic spread HCC tumors 6) Pregnant or breast-feeding patients 7)Known or suspected allergy to iodine or any agents given in this trial 8) Active coronary artery disease less than 3 months prior to study entry 9) Psychological conditions that may interfere with the patient's compliance and evaluation of the study results 10) Evidence of tumor thrombosis in hepatic veins, portal veins, and/or bile ducts 11) Evidence of arterio-portal shunting in liver Any condition that is unstable or which could jeopardize the safety of the subject and their compliance in this study

Design outcomes

Primary

Measure	Time frame
Time to recurrence (TTR)	—

Secondary

Measure	Time frame
Overall survival (OS) Safety	—

Countries

Japan

Contacts

Public ContactManabu Morimoto

Yokohama City University Medical Center Gastroenterological Center

morimoto@urahp.yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026