UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004215 |
|---|---|
| Receipt number | R000005065 |
| Scientific Title | Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2016/07/27 15:24:01 |
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Basic information
Public title
Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma
Acronym
Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma
Scientific Title
Safety and Efficacy Study of Sorafenib in Japanese Child-Pugh A and B Patients with Advanced Hepatocellular Carcinoma
Scientific Title:Acronym
Safety and Efficacy Study of Sorafenib in Japanese patients with Advanced Hepatocellular Carcinoma
Region
| Japan |
Condition
Condition
Advanced Hepatcellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Sorafenib for Japanese Child-Pugh A and B patients with advanced hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Time to Progression (TTP)
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
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 400mg twice daily
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Age >= 20 years
2)Patients who have been diagnosed with hepatocellular carcinoma by histologycally or typical diagnostic images
3)No indication for surgical resection, local thrapy(Percutaneous ethanol injection, radiofrequency ablation, microwave coagulation therapy, transcatheter arterial chemoembolization, radiation therapy)
4)Child-Pugh A or B
5)Performance status (ECOG scale): 0,1 or 2
6)Life expectancy of at least 12 weeks
7)At least 1 target lesion measurable
8)Adequate organ function
Key exclusion criteria
1)Second primary malignancy
2)Severe cardiac complication
3)Active infection
4)HIV infection
5)Encephalopacy
6)Gastro-esophazeal varices requiring preventive treatment
7)Uncontrolled massive ascitis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokosuka |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuou-ku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadahisa Ogasawara |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
ogasawaras@graduate.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
Management information
Registered date
| 2010 | Year | 09 | Month | 15 | Day |
Last modified on
| 2016 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005065
