UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma
Title of the study (Brief title)	Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for 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	This study is plan to clarify the clinical effecacy by the randomized controlled trial using DE Bead and miriplatin in TACE for hepatocellular carcinoma patients in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Anti-tumor response
Key secondary outcomes	Progression free survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TACE with miriplatin
Interventions/Control_2	TACE with DC bead
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)Clinically diagnosed as hepatocellular carcinoma patient. 2)Unresectable hepatocellular carcinoma. 3)20 years of age or older. 4)ECOG performance status 0 or 1. 5)Having measurable lesion in the liver. 6)TMN stage 2 or 3 7)Having indication for TACE. 8)Total birilubin<3.0mg/dl, AST and ALT equal to or less than five times the upper limit. 9)Elapsed 4 weeks or more after previous treatment. 10)Obtained written consent from the patient. 11)Child-Pugh score A or B. 12)Possible to perform the study procedure. 13)Obtained written consent from the patient before study.
Key exclusion criteria	1)Having metastasis. 2)Having vascular invasion. 3)Having vascular anormality or AP shunt. 4)Having previous treatment with miriplatin or DC bead. 5)Having previous treatment with sorafenib. 6)Having severe ascites or pleural effusion. 7)Considered as HCC refractory for TACE. 8)Having allergy of contrast agent. 9)Having severe renal failure. 10)Having severe cardiac disease. 11)Having other cancer. 12)Having hemorrhagic varix. 13)Having severe mental disorder. 14)Having severe drug allergy. 15)Having possibility of pregnant or nursing. 16)Deemed inappropriate to perform the study by the physician.
Target sample size	56

Research contact person
Name of lead principal investigator	Hidemi Goto
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan;
TEL	052-744-2166
Email	hgoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yoji Ishizu
Organization	Nagoya University Graduate School of Medicine, Aichi, Japan
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL	052-744-2169
Homepage URL
Email	y-ishizu@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi, Japan
Institute
Department

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

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	名古屋大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 14 Day
Anticipated trial start date	2014 Year 07 Month 15 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

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

Management information
Registered date	2014 Year 02 Month 20 Day
Last modified on	2017 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015405