A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma

A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma - A combination therapy of CDDP / 5-FU / PEG-IFN alfa-2b for advanced hepatocellular carcinoma. : study of safety and efficacy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009107

Enrollment

Registered

2012-10-13

Start date

2012-10-13

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

Cisplatin (IA-call

Nippon Kayaku Company Ltd.,Tokyo,Japan) : Administrated at a dose of 20mg/m2 by hepatic arterial infusion on days 1 and 15. 5-FU (Kyowa Hakko, Tokyo, Japan) : Administrated at a dose of 250mg/body int

Schering-Plough, Osaka, Japan) :Administrated at a dose of 50-100ug/body in subcutaneously on day 1 of every a week. One treatment cycle lasts 4 weeks and the withdrawal period is 2 weeks to 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age 20-70 years 2.Histologically or clinically confirmed hepatocellular carcinoma 3.Patients with vascular invasion than Vp3 4.Written informed consent was obtained 5.Granulocyte>1500/mm3 6.Hemoglobin>8.5g/dL 7.AST>100 8.ALT>100 9.Total serum bilirubin<2mg/dL 10.Platelet count>80000/uL 11.Serum creatinine<1.5mg/dL 12.PS 0-1

Exclusion criteria

Exclusion criteria: 1. Pregnant or breast-feeding patients. 2. Patients with hypersensitivity to Pt-drug and IFN 3. Severe complication 4. Patients with interstitial pneumonia or a history 5. Patients with central nervous system disorders , the depression or a history 6. Inappropriate patients for this study judged by physicians.

Design outcomes

Primary

Measure	Time frame
Efficacy	—

Countries

Japan

Outcome results

None listed

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