Randomized control trial on efficacy of transcatheter arterial chemoembolization with cisplatin-lipiodol suspension or epirubicin-lipiodol emulsion for hepatocellular carcinoma.

Randomized control trial on efficacy of transcatheter arterial chemoembolization with cisplatin-lipiodol suspension or epirubicin-lipiodol emulsion for hepatocellular carcinoma. - Randomized control trial on efficacy of transcatheter arterial chemoembolization for hepatocellular carcinoma.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001153

Enrollment

360

Registered

2008-05-20

Start date

2007-08-01

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

CDDP-LPD group : Powdered cisplatin suspended in lipiodol and mixed with a contrast medium is injected through the catheter selectively introduced into the hepatic artery, followed by embolizing with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or clinically confirmed hepatocellular carcinoma. 2. Primary cancer, or recurrent cancer that recurred after complete response was obtained by previous treatment with surgical resection, local ablation or TACE. 3. No indication for surgical resection or local ablation. 4. Without extrahepatic metastases. 5. Without tumor thrombosis in portal vein, hepatic vein and bile duct. 6. No massive type or diffuse type tumor 7. Without uncontrolled ascites. 8. Without hepatic encephalopathy. 9. Without marked A-V shunt and A-P shunt. 10. PS is 0 or 1. 11. Child-Pugh is A or B. 12. Sufficient functions of main organ (bone marrow, kidney, heart) and conditions filled the following criteria. 1. WBC >= 3,000/mm3 2. Plt >= 5x104/mm3 3. Hb >= 9.5g/dl 4. T. Bilirubin =< 2.0mg/dl 5. Alb >=2.8g/dl 6. SCr =< upper limit of criteria of each institute. 7. BUN =< 25mg/dl 8. PT >= 50% 13. Age is more than 20 years old and below 80 years old. 14. Life expectancy is more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Active double cancers. 2. Severe complications (excluding chronic hepatitis and liver cirrhosis). 3. Cardiomyopathy , congestive heart failure or medical history of them. 4. Total dose limiting of anticancer drugs with cardiac toxicity, ex. anthracyclin. 5. Medical history of severe hypersensitivity. 6. Pregnant, lactating women or women with suspected pregnancy. 7. Inappropriate patients for this study judged by the physicians.

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Overall survival Safety	—

Countries

Japan

Contacts

Public ContactYoshiyuki Kobayashi

Okayama University Hospital Department of Gastroenterology and Hepatology

ykobaya@md.okayama-u.ac.jp086-235-7219

Outcome results

None listed

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