UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adjuvant InterFeron After Curative Resection of HCV-related Hepatocellular Carcinoma in Elderly Patients: a Multicenter Randomized Controlled Trial
Title of the study (Brief title)	iFACT trial
Region	Japan

Condition
Condition	HCV-related hepato cellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate and clarify the efficacy and safety of adjuvant interFeron therapy after curative resection of HCV-related hepatocellular carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Recurence free survival
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Adjuvant interferon alpha therapy. Three times of 3,000,000 units / a week.
Interventions/Control_2	Close follow-up
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	61 years-old <=
Age-upper limit	77 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Ages between 61 and 77 years old 2) Primary HCC or recurrent HCC more than two years after previous therapy 3) Classical HCC 4) HCV chronic hepatitis or cirrhosis 5) No extrahepatic lesions 6) Fine or moderate organ function fulfilling the following criteria. 7) Child-Pugh score < 8 8) ECOG performance status 0-2 9) CES-D score <16 10) Written informed consent
Key exclusion criteria	1) Positive HBs-Ag 2) Other anticancer treatment or interferon therapy within 3 months before surgery. 3) Specific drug which is forbidden in this trial is needed. 4) Participating in other clinical trial regarding HCC 5) Autoimmune hepatitis, alcoholic hepatitis, etc. 6) Allergy for specific biologics 7) Severe postoperative complications 8) Asthma 9) Diabetes requiring insulin therapy 10) Severe hypertension 11) Heart disease that complicates perioperative treatments 12) Interstitial pneumonia 13) Psychiatric disorder 14) Malignant disease in other organ within 5 years 15) Moderate or severe renal dysfunction (estimated Ccr < 30ml/min) 16) Other reason that an attending doctor considers
Target sample size	300

Research contact person
Name of lead principal investigator	Norihiro Kokudo
Organization	Tokyo University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	kihase-tky@umin.ac.jp

Public contact
Name of contact person	Takeaki Ishizawa
Organization	Tokyo University Hospital
Division name	Hepato-Biliary-Pancreatic Surgery Division
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	kihase-tky@umin.ac.jp

Sponsor
Institute	Tokyo University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2011 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 24 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 04 Month 17 Day
Last modified on	2017 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006368