UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026838
Receipt number R000030627
Scientific Title Randomized control trial of blant-TAE with embosphere or gelpart for large hepatocellular carcinoma
Date of disclosure of the study information 2017/05/01
Last modified on 2020/10/05 12:50:05

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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 or person

Institute

Kitasato University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030627


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name