UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the efficacy between DEB(drug-eluting-bead)-TACE and hepasphere with the use of epirubicin :a randomized prospective phase 2 trial
Title of the study (Brief title)	BHEP
Region	Japan

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

Objectives
Narrative objectives1	Comparison of the safety and efficacy between DEB-TACE and Hepasphere with the use of epirubicin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	safety
Key secondary outcomes	Time to local progression MST TE mRESICT

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Device,equipment
Interventions/Control_1	DC bead
Interventions/Control_2	hepasphere
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with histologically or radiographically diagnosed HCC patients over 20 years old with informed consent form singed patients must have a life expectancy of at least 6 months EOCG performanc status 0 or 1 Patients who are recived systemic or
Key exclusion criteria	patients with extrahepatic and metastasis of the lymph node macroscopic vascular invasion active serious infection exept for hepatic B or C infection active cancer Pregnant or lacting women
Target sample size	80

Research contact person
Name of lead principal investigator	takuzi torimura
Organization	kurume university
Division name	gastroenterology
Address	67,asahi-machi,kurume-shi,fukuoka,830-0011,Japan
TEL	0942-35-3311
Email	tori@med.kurume-u.ac.jp

Public contact
Name of contact person	shigeo shimose
Organization	kurume university
Division name	gastroenterology
Address	67,asahi-machi,kurume-shi,fukuoka,830-0011,Japan
TEL	0942-35-3311
Homepage URL
Email	shimose_shigeo@med.kurume-u.ac.jp

Sponsor
Institute	kurume university
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	久留米大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 04 Month 18 Day
Anticipated trial start date	2014 Year 05 Month 15 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	2014 Year 05 Month 15 Day
Last modified on	2016 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016268