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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029504
Receipt No. R000033711
Scientific Title Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study
Date of disclosure of the study information 2017/10/11
Last modified on 2017/10/11

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Basic information
Public title Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study

Acronym B-TACE study
Scientific Title Balloon occluded transarterial chemoembolization using miriplatin in HCC: A Multicenter, Clinical Phase II study

Scientific Title:Acronym B-TACE study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate effectiveness and safety of balloon occluded transarterial chemoembolization using miriplatin in HCC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate in largest tumor (3 months after treatment)
Key secondary outcomes Adverse events, progression-free survival, overall survival, response rate of HCC treated by B-TACE (3 months), achievement rate of B-TACE

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
Interventions/Control_1 Balloon occluded transarterial chemoembolization using miriplatin
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1). Histologically or clinically confirmed hepatocellular carcinoma. The largest tumor is<= 5cm. The number of HCC in the patient is within 4 (local recurrent lesion is not allowed).
2). Without major portal invasion (Vp3 or Vp4)
3). Target lesion is not treated.
4). Child-Pugh A or B
5). not the candidate of surgery
6). Adequate organ functions: bone marrow, Heart, renal function (14 days before entry)
Neutro =>1,500/mm3
HGB =>8.5g/dl
Plt >=5.0x104/mm3
T-Bil <=2.0mg/dl
AST <= 5 times ULN
ALT <= 5 times ULN
PT% > 50%
Serum Cre <=1.5 times ULN
7). Over 18 years old
8). ECOG Performance Status 0 or 1
9). Expected survival time over 12 weeks
10). Written informed consent
Key exclusion criteria 1) Bile duct injury(bile duct dilatation), reconstruction of the biliary tract history, history of endoscopic biliary treatment
2) Severe arterio-portal shunting
3) Severe arterial stenosis or obstruction in CECT or AAG
4) Severe ascites or pleural effusion
5) Major portal invation (Vp3 or Vp4)
6) Severe complication (cardiac failure, arrhythmia, angina pectoris, myocardial infarction within 6 months, double cancer, active infection, gastrointestinal bleeding, severe hepatic encephalopathy, severe allergya for
contrast media or medicine)
7) Pregnant, nursing or possible pregnant woman
8) Qualified ineligible patients being this clinical trial by responsible doctor
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Yamakado
Organization Hyogo College Of Medicine College
Division name Department of Radiology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6111
Email yamakado47@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamamoto
Organization Osaka City Univercity
Division name Department of Radiology
Zip code
Address 1-4-3, Asahi-machi,Abebo-ku, Osaka, Osaka
TEL 06-6645-3831
Homepage URL
Email loveakirayamamoto@gmail.com

Sponsor
Institute 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 Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 11 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 11 Day
Last modified on
2017 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033711

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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