Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma - ACE 500 Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001384

Enrollment

450

Registered

2008-10-14

Start date

2008-09-01

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

Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pomping. Then this suspension is adminis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has mesurable lesions. 2. Subject must to be the first experience of TACE. 3. Subject has no extra-hepatic tumor and no obstruction of main portal vein. 4. Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy). 5. ECOG performance status 0-2 6. Child-pugh Class A or B 7. Subject must have adequate functions of bonemarrow, renal, circuratory organs and appropriate examination results as below: 1) Serum Total Bilirubin 2.0mg/mL 2) WBC 3000/mm3 3) PLT 50000/mm3 4) Hb 9.0g/dL 5) Creatinine ; upper normal limit (UNL) 6) BUN 25mg/dL 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Subject has extra hepatic metastasis. 2. Tumor thrombosis exists at main portal vein. 3. Remarkable artery-portal vein shunt or veno-arterial shunt. 4. Uncontrollable ascites or pleural effusion. 5. History of severe hypersensitivity. 6. Any previous TACE or TAE for HCC. 7. Any previous chemotherapy using epirubicin or CDDP. 8. Complications as below (except chronic hepatitis or liver cirrhosis) 1) Severe heart disease 2) Myocardial infarction within 6 months 3) Renal insufficiency 4) Active infections (except virous hepatitis) 5) Gastrointestinal bleeding 6) Active double cancer 7) Hepatic encephalopathy or heavy mental disorder. 9.Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. 10. Any subject judged by the investigator to be unfit for any reason to participate in the study.

Design outcomes

Primary

Measure	Time frame
P-II part: Response Rate P-III part: Overall survival	—

Secondary

Measure	Time frame
P-II part: Adverse events P-III part: Time to treatment failure, response rate, adverse events	—

Countries

Japan

Contacts

Public ContactMasamichi Moriguchi

Nihon University School of Medicine Devision of Digestive Surgery

moriguchi.masamichi@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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