Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma

Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma - Evaluation of clinical effects of NFP therapy and sorafenib for advanced HCC

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003917

Enrollment

Registered

2010-07-15

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

unresectable advanced hepatocellular carcinoma

Interventions

5-FU+CDDP with lipiodol sorafenib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) unresectable HCC 2) Child-Pugh class A 3) Performance status: ECOG 0-1 4) no influence of prior therapy 5) Serum creatinine; less than 1.5 mg/dl, WBC: more than 2000, Total bilirubine: less than 2 mg/dl , no uncontrolable ascites, no hepatic encephalopathy, Platelet: more than 50,000, Hb: more than 8.5 g/dl,

Exclusion criteria

Exclusion criteria: 1) extrahepatic metastasis 2) pregnant woman 3) drug allergy

Design outcomes

Primary

Measure	Time frame
time to progression therapeutic efficacy	—

Secondary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactTakuji Torimura

Kurume University, School od Medicine Department of Medicine, Division of Gastroenterology

tori@med.kurume-u.ac.jp0942-31-7561

Outcome results

None listed

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