A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma

A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma - A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002401

Enrollment

140

Registered

2009-09-01

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

Interventions

Experimental arm 5-FU arterial infusion and interferon therapy (FAIT) Reference arm Sorafenib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with hepatocellular carcinoma which was diagnosed pathologically or by typical radiological findings on enhanced CT or MRI within 4 weeks before registration. 2) Patients with hepatocellular carcinoma which is not eligible for surgical and percutaneous locoregional therapies and is refractory to other conventional therapies such as transcatheter hepatic arterial chemoembolization, with and without portal vein tumor thrombus. 3) Patients with no extrahepatic metastases. In paticular, metastases to the brain should be ruled out on CT or MRI in suspected patients. 4) Patients who has not received any treatment for hepatocellular carcinoma in the last 4 weeks before registration. 5) Patients aged 20-79 years. 6) Patients with Eastern Cooperative Oncology Group Performans Status of 0 or 1. 7) Patients with adequate hematological, hepatic and renal function, as indicated by Hemoglobin concentration of 8.0g/dl or more White blood cell count between 3000 and 12000 /mm3 Platelet count of 40000/mm3 or more Child-Pugh classification A Serum creatinine concentration of 1.5 mg/dl or less 8) Patients without severe cardiac, pulmonary or psychiatric comorbidities. 9) Patients without any other malignant disease, or with malignancy at least 5 years after curative treatment. 10) Patients agreeing to use adequate contraception methods during the trial. 11) Women who are not pregnant or lactating, and not expecting future pregnancy. 12) Patients who are judged adequate to participate by the atending physician.

Exclusion criteria

Exclusion criteria: See inclusion criteria.

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
Response rate, progression-free survival, response in tumor markers, incidence and severity of adverse events	—

Countries

Japan

Contacts

Public ContactYuji Kondo

University of Tokyo Hospital Department of Gastroenterology

ykon-tky@umin.ac.jp

Outcome results

None listed

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