Skip to content

pilot study of hepatic resection followed by intraarterial 5-fluorouracil/cisplatin combination therapy for advanced hepatocellular carcinoma with vascular invasion

pilot study of hepatic resection followed by intraarterial 5-fluorouracil/cisplatin combination therapy for advanced hepatocellular carcinoma with vascular invasion - hepatic resection followed by low dose FP for HCC with vascular invasion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002930
Enrollment
20
Registered
2009-12-22
Start date
2009-09-01
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 with vascular invasion

Interventions

1) hepatic resection 2) low dose FP One course of chemotherapy represented 2 weeks. 5FU (300 mg/m2/24h) was administered using a mechanical infusion pump on days 1-5 of the first and second weeks.

Sponsors

Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Biomedical Research, Graduate School of Biomedical, Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Diagnosis of HCC was confirmed histopathologically or clinically. 2) no adaptation of liver transplantation and local abration. 3) with Vp3/4 or Vv2/3 or B3/4 4) without uncontrollable ascites 5) without hepatic coma 6) PS 0-1 7) chronic hepatitis or Child-Pugh A 8) WBC > 3000/mm3 Plt > 80000/mm3 Hb > 10.0 g/dl Total Bilirubin < 2.0 mg/dl Albumin > 3 g/dl Creatine < 1.2mg/dl Prothromin time > 60 percentage

Exclusion criteria

Exclusion criteria: 1) With other malignant disease. 2) A pregnant woman, or a woman suspected of pregnancy. 3) With severe infectious disease. 4) With history of severe allergy. 5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP. 7) With severe bone marrow supression.

Design outcomes

Primary

MeasureTime frame
overall survival

Secondary

MeasureTime frame
1) time to progression 2) safety 3) response rate

Countries

Japan

Outcome results

None listed

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