Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study-

Combination therapy of 5-Fluorouracil/gemcitabine/cisplatin for advanced hepatocellular carcinoma with extrahepatic metastases -A pilot study- - Combination therapy of 5FU/gemcitabine/CDDP for advanced HCC with extrahepatic metastases -A pilot study-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000719

Enrollment

Registered

2007-05-22

Start date

2007-05-07

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 extrahepatic metastases

Interventions

The combination therapy of 5FU/gemcitabine/CDDP. Contunue the protocol as long as progression disease is observed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Unresectable hepatocellular carcinoma with extrahepatic metastases. Child Pugh A. Not suitable candidate for S-1 and IFN therapy. Without ascites. Without hepatic coma. Eastern cooperative Oncology Group 0, or 1. WBC > 2000/mm3 Plt > 100000/mm3 Hb > 10.0g/dl Total Bilirubin < 2.0mg/dl Albumin > 2.8g/dl Creatine < 1.2mg/dl Prothromin time > 40 percentage

Exclusion criteria

Exclusion criteria: With other malignant disease. A pregnant woman, or a woman suspected of pregnancy. With severe infectious disease. With history of severe allergy. With severe renal function disease. With S-1. With severe allergy for 5FU, gemcitabine, or CDDP. With severe bone marrow supression. With pulmonary fibrosis. With the history of radiotharpy for lung.

Design outcomes

Primary

Measure	Time frame
Response for extrahepatic metastases	—

Secondary

Measure	Time frame
Overall survival Safety	—

Countries

Japan

Contacts

Public ContactKiminori Uka

Hiroshima University Department of Medicine and Molecular Science, Division of Frontier Medical Science, Programs for Bio

Outcome results

None listed

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