UMIN-CTR Clinical Trial

Basic information
Public title	Randomized control trial of blant-TAE with embosphere or gelpart for large hepatocellular carcinoma
Acronym	BEWELL study
Scientific Title	Randomized control trial of blant-TAE with embosphere or gelpart for large hepatocellular carcinoma
Scientific Title:Acronym	BEWELL study
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 efficacy and the safety between embosphere and gelpart for blant-TAE of large hepatocellular carcinoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate(4 weeks)
Key secondary outcomes	Tumor contraction rate. Time to progression. Safety. Overall survival rate.

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
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	embosphere
Interventions/Control_2	gelpart
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)Histologically or clinically diagnosed as hepatocellular carcinoma. 2)Tumor size 5cm or larger. 3)No candidate for surgery or ablation therapy. 4)Five or fewer tumors (>2 cm) 5)Child-Pugh classification A or B. 6)Expected survival time over 3 months. 7)Without dysfunction of bone marrow, heart, lung, kidney.
Key exclusion criteria	1)Invasion of main portal vein (Vp3, Vp4) or inferior vena cava. 2)Hepatic encephalopathy or refractory ascites. 3)Allergy to contrast media. 4)Pregnant, possibly pregnant. 5)Patients who are not suitable to be participated due to medical reason evaluated by primary physician
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yoshiaki Middle name Last name Tanaka
Organization	Kitasato University
Division name	Departments of Gastroenterology
Zip code	252-0329
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Email	tanakay@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Yoshiaki Middle name Last name Tanaka
Organization	Kitasato University
Division name	Departments of Gastroenterology
Zip code	252-0329
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL	042-778-8111
Homepage URL
Email	tanakay@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
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)

IRB Contact (For public release)
Organization	Kitasato University School of Medicine
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel	042-778-8111
Email	tanakay@kitasato-u.ac.jp

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	北里大学病院（神奈川県）、医療法人 沖縄徳洲会 湘南鎌倉総合病院（神奈川県）、医療法人　徳洲会　湘南藤沢徳洲会病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2017 Year 05 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	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 27 Day
Date of IRB	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 27 Day
Last follow-up date	2030 Year 04 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	2017 Year 04 Month 03 Day
Last modified on	2020 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030627