UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005847 |
|---|---|
| Receipt number | R000006898 |
| Scientific Title | Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma : Safety and effectiveness |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2013/12/26 10:07:27 |
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Basic information
Public title
Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness
Acronym
Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness
Scientific Title
Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness
Scientific Title:Acronym
Sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
: Safety and effectiveness
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
safety and effectiveness of sorafenib in TACE-refractory or TACE-failure advanced hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
time to progression, time to treatment failure, overall survival, response rate, disease control rate, safety
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.TACE-refractory or TACE-failure advanced hepatocellular carcinoma
2.patients appropriate to use sorafenib
3.Child-Pugh score:A
ECOG PS:0-1
Hemoglobin >8.5 g/dL
Neutorophil >1500 /micro L
Platelet >75000 /micro L
total bilirubin <2 mg/dL
AST, ALT <5 times the upper limit of the normal range in local laboratories
Key exclusion criteria
1.Patients unsuitable for Sorafenib
Allergic reaction to Sorafenib, Pregnant women, Poor renal function(required hemodialysis), Past history of thromboembolism or ischemic heart disease
Poor control of hypertension
2.Severe vascular invasion(Vp3,4)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Hatano |
Organization
Kyoto university hospital
Division name
surgery
Zip code
Address
54 Kawarachou shougoin sakyouku kyoto
TEL
075-751-3242
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kohta Iguchi |
Organization
Kyoto university hospital
Division name
surgery
Zip code
Address
54 Kawarachou shougoin sakyouku kyoto
TEL
075-751-3242
Homepage URL
iguchik@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
Trust accounts
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Safety and efficacy of sorafenib
Management information
Registered date
| 2011 | Year | 06 | Month | 26 | Day |
Last modified on
| 2013 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006898
