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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033954
Receipt No. 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 2019/08/31

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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
Middle name
Last name Onishi Hideki
Organization Okayama university hospital
Division name Gastroenterology and Hepatology
Zip code
Address 2-5-1, shikata-cho, Okayama, Okayama
TEL 086-235-7219
Email at841205@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Oyama
Organization okayama university hospital
Division name Gastroenterology and Hepatology
Zip code
Address 2-5-1, shikata-cho, Okayama, Okayama
TEL 086-235-7219
Homepage URL
Email at841205@gmail.com

Sponsor
Institute okayama university hospital
Institute
Department

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
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
2018 Year 10 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 Enrolling by invitation
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
2019 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038475

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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