Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00843934

Acronym

ACE500

Enrollment

450

Registered

2009-02-13

Start date

2009-03-31

Completion date

2015-02-28

Last updated

2012-10-19

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

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, Hepatocellular, Trans arterial chemoembolization, Epirubicin, Cisplatin

Brief summary

The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).

Interventions

DRUGepirubicin

Arm E: Suspension is prepared before arterial infusion as follows: Epirubicin is dissolved with water-soluble, non-ionized contrast medium then mixed with Lipiodol by pumping. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of EPI and Lipiodol are 60mg/m2 and 0.3mL/Kg, respectively.

DRUGCisplatin

Arm C: Suspension is prepared before arterial infusion as follows: Cisplatin (Water soluble CDDP: IA CALL) is mixed with Lipiodol. Then this suspension is administered by catheter as quick as possible, and gelatin is infused for arterial embolization. Maximum dose of Cisplatin and Lipiodol are 65mg/m2 and 0.3mL/Kg, respectively.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions. * Subject must to be the first experience of TACE. * Subject has no extra-hepatic tumor and no obstruction of main portal vein. * Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy). * ECOG performance status 0-2 * Child-pugh Class A or B * Subject must have adequate functions of bonemarrow, renal, circulatory 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 * Written informed consent

Exclusion criteria

* Subject has extra hepatic metastasis. * Tumor thrombosis exists at main portal vein. * Remarkable artery-portal vein shunt or veno-arterial shunt. * Uncontrollable ascites or pleural effusion. * History of severe hypersensitivity. * Any previous TACE or TAE for HCC. * Any previous chemotherapy using epirubicin or CDDP. * 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. * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant. * Any subject judged by the investigator to be unfit for any reason to participate in the study.

Design outcomes

Primary

Measure	Time frame
response rate	6 months

Countries

Japan

Contacts

Primary ContactMasashi Fujii, MD

masashi.fujii@gioncology.jp+81332981711

Backup ContactTadatoshi Takayama, MD

Takayama.Tadatoshi@nihon-u.ac.jp+81339728111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026