UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033954 |
|---|---|
| Receipt number | R000038475 |
| Scientific Title | Trial of DEB-TACE using hepasphere with cisplatin against multiple hepatocellular carcinoma |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2022/08/23 01:19:23 |
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Basic information
Public title
Trial of DEB-TACE using hepasphere with cisplatin against multiple hepatocellular carcinoma
Acronym
Trial of DEB-TACE using hepasphere with cisplatin against multiple hepatocellular carcinoma
Scientific Title
Trial of DEB-TACE using hepasphere with cisplatin against multiple hepatocellular carcinoma
Scientific Title:Acronym
Trial of DEB-TACE using hepasphere with cisplatin against multiple 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
efficiency and safety about DEB-TACE using CDDP against multiple 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(treated after four-twelve weeks)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Product name: IA-call
Product name: Hepasphere
Protocol treatment procedure:
Perform DEB-TACE using Hydrocol-impregnated Hepaspire from hepatic arterial segment branches according to the area to be treated. If the effectiveness can be confirmed by image examination of effect judgment, it is possible to repeat the same treatment by confirming that the next course start criterion is satisfied at the interval of more than 4 weeks of protocol treatment last time.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HCC
tumor number 3 < tumor size < 30mm
Child-Pugh A or B
BCLC stage A or B
Age 20-90
ECOG performance status 0-1
4 week later after previous therapy
TACE therapy within 4 times
Laboratory data is in normal range
get concent in writing
expect survival for over 8 weeks
Key exclusion criteria
not HCC
previously treated by hepatic arterrial infusion therapy
invesion of artery, vein or biliary duct
extrahepatic lesion
HCC rupture
unsuitable for TACE
HCC dominated by localized vessels
unsuitable for CDDP
To have other cancers
To have serious complications
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Onishi |
Organization
Okayama university hospital
Division name
Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1, shikata-cho, Okayama, Okayama
TEL
086-235-7219
at841205@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Oyama |
Organization
okayama university hospital
Division name
Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1, shikata-cho, Okayama, Okayama
TEL
086-235-7219
Homepage URL
at841205@gmail.com
Sponsor or person
Institute
okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
okayama university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama saiseikai general hospital, Okayama city general medical center, Japanese red cross Okayama hospital, Kagawa prefectural central hospital, Kurashiki central hospital, Tsuyama chuo hospital, Hiroshima city Hiroshima citizens hospital, Mitoyo general hospital, Himeji central hospital, Fukuyama city hospital, National hospital organization Fukuyama medical center, Sumitomo Bessshi hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama university hospital
Address
2-5-1, Shikata-cho, Okayama
Tel
0862357219
at841205@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
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
no data
Publication of results
Unpublished
Result
URL related to results and publications
no data
Number of participants that the trial has enrolled
2
Results
Trial canceled
Results date posted
| 2022 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 20 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 30 | Day |
Last modified on
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038475
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
