UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Acronym	A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Scientific Title	A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Scientific Title:Acronym	A randomized controlled trial of sorafenib versus 5-FU arterial infusion and interferon therapy (FAIT) for advanced hepatocellular carcinoma
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of 5-FU arterial infusion and interferon thearpy (FAIT) in comparison with sorafenib in patients with advanced hepatocellular carcinoma which is not eligible for or refractory to surgical or locoregional therapies, or transcatheter hepatic arterial chemoembolization.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Response rate, progression-free survival, response in tumor markers, incidence and severity of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Experimental arm 5-FU arterial infusion and interferon therapy (FAIT)
Interventions/Control_2	Reference arm Sorafenib
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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.
Key exclusion criteria	See inclusion criteria.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shuntaro Obi
Organization	Kyoundo Hospital
Division name	Department of Hepatology
Zip code
Address	1-8 kanda-surugadai, Chiyoda-Ku, Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Yuji Kondo
Organization	University of Tokyo Hospital
Division name	Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email	ykon-tky@umin.ac.jp

Sponsor
Institute	Department of Hepatology, Kyoundo Hospital
Institute
Department

Funding Source
Organization	Sasaki fundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 08 Month 27 Day
Date of IRB	2009 Year 08 Month 01 Day
Anticipated trial start date	2009 Year 09 Month 01 Day
Last follow-up date	2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 08 Month 29 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002928