UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of Sorafenib combined with on-demand Transarterial Chemoembolization for Advanced Hepatocellular Carcinoma (Barcelona Clinic Liver Cancer stage C)
Title of the study (Brief title)	STAB study
Region	Japan

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

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of complete a protocol treatment
Key secondary outcomes	Adverse event, Survival time, Tumor response

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Sorafenib with Transarterial chemoembolization
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Hepatocellular carcinoma 2. First line systemic chemotherapy 3. BCLC stage C 4. ECOG PS 0, 1 5. Child Pugh A
Key exclusion criteria	1. Tumor thrombus of main or first branch portal vein 2. Brain metastasis
Target sample size	32

Research contact person
Name of lead principal investigator	Koichiro Yamakado
Organization	Mie University
Division name	Department of Interventional Radiology
Address	2-174 Edobashi, Tsu, Mie, Japan, 514-8507
TEL	059-232-1111
Email	yama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Yozo Sato
Organization	Aichi Cancer Center Hospital
Division name	Department of Diagnostic and Interventional Radiology
Address	1-1, Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan, 464-8681
TEL	052-762-6111
Homepage URL
Email	ysato@aichi-cc.jp

Sponsor
Institute	Clinical Research Group of the Japanese Society for Transcatheter Hepatic Arterial Embolization
Institute
Department

Funding Source
Organization	the Japanese Society for Transcatheter Hepatic Arterial Embolization
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	2014 Year 06 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 29 Day
Anticipated trial start date	2013 Year 07 Month 29 Day
Last follow-up date	2016 Year 09 Month 25 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 10 Month 16 Day
Date analysis concluded	2017 Year 04 Month 10 Day

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

Management information
Registered date	2014 Year 06 Month 09 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013463