Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC

Phase I study of hepatic arterial infusion chemotherapy with Miriplatin and 5-fluorouracil(MiF) for advanced HCC - Phase I study of MiF for advanced HCC

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003302

Enrollment

Registered

2010-04-01

Start date

2010-03-01

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

inpatient therapy:administration via the implanted port of Miriplatin(65mg/m2,ia,day1) and 5-FU(850mg/m2,cia,day1-5and 8-12) into the hepatic artery. outpatient therapy:administration via the implant

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,second branch)or multinodular tumor and maximum tumor size is >=50mm. 4.Ages 30 to 79 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>=2000/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 Ejection fraction>=45% PaO2>=60mmHg 8.Written informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1.Previous chemothrapy or TAE 2.Previous operation or RFA or PEIT within 6 months. 3.Extrahepatic metastasis or lymph 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

Measure	Time frame
complication	—

Secondary

Measure	Time frame
response evaluation overall survival	—

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