Skip to content

Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC

Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC - The study of NFP for advanced HCC

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002073
Enrollment
50
Registered
2009-07-01
Start date
2007-05-01
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

hospitalization therapy administration via the implanted port of Cisplatin/lipiodol suspension(50mg/body,ia,day1,8) and 5-FU(1250mg/body/day, cia day1-5,8-12) into the hepatic artery every two weeks.

Sponsors

Division of Gastroenterology,Kurume University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically or clinically confirmed hepatocellular carcinoma. 2.No indication for transplantation or surgical resection. 3.Portal vein tumor thrombosis(main trunk or first branch) or multinodular tumor and maximum tumor size is >=50mm. 4.Ages 30 to 80 years old. 5.EOCG performance status is 0 or 1. 6.Life expectancy is more than 3 months. 7.Sufficient function of main organ(bone marrow, kidney,heart)and conditions filled the following criteria. WBC>=2,000/mm3 Hb>=8.5g/dL Plt>=50,000/mm3 Child-Pugh score<9 T-bil=<2.0mg/dL Without uncontrolled ascites and hepatic encephalopathy. S-Cr=<1.5mg/dL or CCr>=50mL/min Ejection fraction>=45% PaO2>=60mmHg 8.Written informed consent was obtained

Exclusion criteria

Exclusion criteria: 1.previous chemotherapy or TAE 2.Previous operation or RFA or PEIT within one year 3.Extrahepatic metastasis or nodes metastasis 4.Concurrent infections(without hepatitis virus) 5.Active double cancers 6.Medical history of severe hypersensitivity. 7.Pregnant,lacting women or women with suspected pregnancy. 8.Inappropriate patients for this study judged by physicians.

Design outcomes

Primary

MeasureTime frame
Progrssion free survival

Secondary

MeasureTime frame
Overall survival response evaluation complicasion

Countries

Japan

Contacts

Public ContactHiroaki Nagamatsu

Yame General Hospital Department of Gastroenterology and Hepatology

ymhp0389@yamehp.jp0943-23-4131

Outcome results

None listed

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