UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029504 |
|---|---|
| Receipt number | 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 | 2025/04/20 01:39:17 |
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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 | Koichiro |
| Middle name | |
| Last name | Yamakado |
Organization
Hyogo College Of Medicine College
Division name
Department of Radiology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6111
yamakado47@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | Akira |
| Last name | Yamamoto |
Organization
Osaka Metropolitan Univercity
Division name
Department of Radiology
Zip code
545-8585
Address
1-4-3, Asahi-machi,Abebo-ku, Osaka, Osaka
TEL
06-6645-3831
Homepage URL
loveakirayamamoto@gmail.com
Sponsor or person
Institute
The Japanese Society for Transcatheter Hepatic Arterial Embolization
Institute
Department
Personal name
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
Osaka Public University Medical Research Ethics Review Committee
Address
1-4-3, Asahi-machi,Abebo-ku, Osaka, Osaka
Tel
06-6645-3456
loveakirayamamoto@gmail.com
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 19 | 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 | 10 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033711
