UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014999 |
|---|---|
| Receipt number | R000017427 |
| Scientific Title | Comparison of Sorafenib and DEB-TACE in patients wth hepatocellular carcinoma refractory to conventional TACE. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2019/09/19 20:19:33 |
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Basic information
Public title
Comparison of Sorafenib and DEB-TACE in patients wth hepatocellular carcinoma refractory to conventional TACE.
Acronym
The investigation for the therapy of hepatocellular carcinoma refractory to conventional TACE.
Scientific Title
Comparison of Sorafenib and DEB-TACE in patients wth hepatocellular carcinoma refractory to conventional TACE.
Scientific Title:Acronym
The investigation for the therapy of hepatocellular carcinoma refractory to conventional TACE.
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the best therapy for hepatocellular carcinoma refractory to conventional TACE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival rate
Key secondary outcomes
progression-free survival
response rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1)Patients with HCC.
2)Patients whose TMN stage of HCC is II, III or IVa.
3)Patiets that written agreement of participation for this study was obtained.
4)Patients with HCC refractory to conventional TACE.
5)Patients whose Child-Pugh is A.
Key exclusion criteria
1)Patiets that written agreement of participation for this study was not obtained.
2)Patients whose HCC with invasion of stem of portal vein.
3)Patients with uncontrollable ascites.
4)Patients whose TMN stage of HCC is IVb.
5)Patients whose Child-Pugh is B or C.
6)Pregnant patiients.
7)Patients with iodine hypersensitivity.
8)Patients who were estimated that study entry is inappropriate by the responsible physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kouji Joko |
Organization
Matsuyama Red Cross Hospital
Division name
Center for liver-Billiary-Pancreatic Diseases
Zip code
Address
1 Bunkyo-cho, Matsuyama, Ehime, Japan
TEL
089-924-1111
koujijoko@matsuyama.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hironori Ochi |
Organization
Matsuyama Red Cross Hospital
Division name
Center for liver-Billiary-Pancreatic Diseases
Zip code
Address
1 Bunkyo-cho, Matsuyama, Ehime, Japan
TEL
089-924-1111
Homepage URL
hironori19810211@matsuyama.jrc.or.jp
Sponsor or person
Institute
Musashino Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grants for Research on Hepatitis from Ministry of Health, Labor and Welfare, Japan.
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 | 09 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of Sorafenib and DEB-TACE in patients with hepatocellular carcinoma refractory to conventional TACE: The investigation by Jananese red cross liver study group.
Management information
Registered date
| 2014 | Year | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017427
| Research Plan | |
|---|---|
| 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 |
