UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013461 |
|---|---|
| Receipt number | R000015718 |
| Scientific Title | Combination therapy with a molecular target drug and iron chelator for the treatment of intractable hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/03/19 |
| Last modified on | 2016/07/13 09:17:00 |
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Basic information
Public title
Combination therapy with a molecular target drug and iron chelator for the treatment of intractable hepatocellular carcinoma
Acronym
Combination chemotherapy for the treatment of hepatocellular carcinoma
Scientific Title
Combination therapy with a molecular target drug and iron chelator for the treatment of intractable hepatocellular carcinoma
Scientific Title:Acronym
Combination chemotherapy for the treatment of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the therapeutic effect and safety of the combination therapy with sorafenib and deferasirox for the treatment of hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety and compliance
Key secondary outcomes
antitumor effect
time to tumor progression
overall survival
effect to liver function and iron level
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
Sorafenib and deferasirox
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
Sorafenib intractable hepatocellular carcinoma
Child-Pugh A
Key exclusion criteria
active double cancers
severe complications
contraindication of the test drugs
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Yamamoto |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city
TEL
+81-86-235-7219
kazuhide@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Nouso |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama city
TEL
+81-86-235-7219
Homepage URL
nouso@cc.okayama-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
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
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
| 2014 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 07 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 19 | Day |
Last modified on
| 2016 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015718
