A prospective randomized controlled trial of selective conventional TACE vs. balloon occluded TACE with epirubicin for hepatocellular carcinoma

A prospective randomized controlled trial of selective conventional TACE vs. balloon occluded TACE with epirubicin for hepatocellular carcinoma - A randomized controlled trial of selective conventional TACE vs. balloon occluded TACE for hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026897

Enrollment

164

Registered

2017-04-10

Start date

2017-04-10

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

Patients with hepatocellular carcinoma who are scheduled to underwent TACE

Interventions

Micro balloon catheter Microcatheter

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven or clinically diagnosed hepatocellular carcinoma. 2. No prospective candidate for hepatectomy, liver transplantation, or local ablation therapy (judged by investigators). 3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection. 4. Measurable HCC nodules in which TACE is planned. 5. No previous treatment for HCC nodules in which TACE is planned. 6. Without tumor thrombosis in main portal branch or portal trunk. 7. Performance status (ECOG) of 0 to 2. 8. Child Pugh class A or B. 9. Maximum HCC size <=5cm and total number<=3. 10. No major organ failure and all the laboratory data, below are conserved. 1) T.Bil<=3.0 mg/dL 2) WBC>=3,000/mm3 3) PLT>=50,000/mm3 11. Age of 20 years or over. 12. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Extrahepatic metastasis. 2. Ruptured HCC nodules in which TACE is planned. 3. Prior surgical reconstruction or endoscopic treatment of the biliary tract. 4. Severe arterio portal or arterio venous shunts in the liver. 5. Refractory ascites or pleural effusion. 6. Allergy to contrast medium that precludes angiography. 7. Previously registered patients in this study. 8. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception. 9. Comorbid diseases as cardiac failure, recent myoinfarction, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders, and serious allergy to medicine. 10. Not eligible because of safety issues judged by investigators.

Design outcomes

Primary

Measure	Time frame
Tumor Response at 3 month after TACE	—

Secondary

Measure	Time frame
Adverse events Success rate of TACE Tumor Response based on location	—

Countries

Japan

Contacts

Public ContactTeiji Kuzuya

Nagoya University Graduate School of Medicine Department of Gastroenterology and Hepatology

tkuzuya@med.nagoya-u.ac.jp052-744-2169

Outcome results

None listed

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