UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007488 |
|---|---|
| Receipt number | R000008778 |
| Scientific Title | To evaluate the effect of Sorafenib with TACE for intrahepatic metastasis of hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/03/12 |
| Last modified on | 2014/04/10 15:47:54 |
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Basic information
Public title
To evaluate the effect of Sorafenib with TACE for intrahepatic metastasis of hepatocellular carcinoma
Acronym
To evaluate the effect of Sorafenib with TACE for intrahepatic metastasis of hepatocellular carcinoma
Scientific Title
To evaluate the effect of Sorafenib with TACE for intrahepatic metastasis of hepatocellular carcinoma
Scientific Title:Acronym
To evaluate the effect of Sorafenib with TACE for intrahepatic metastasis of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of TACE with Sorafenib for intrahepatic metastasis in patients with hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The frequency of intrahepatic metastasis
Key secondary outcomes
Response rate
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TACE alone
Interventions/Control_2
TACE with Sorafenib
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.unresectable HCC who are not candidates for surgical resection or local therapy
2.Child pugh scoreA
3.Patients with tumors which are confirmed to the liver and can be treated by TACE(the maximum number of nodule equal to or less than 10).
4.Normal renal function(Cre<1.30,
e-GFR>60ml/min)
5.Patients who were fully informed of the study beforehand and signed the informed consent to participate in the study
Key exclusion criteria
1.History of malignant tumor
2.Occlusion of the main trunk or first branch of Portal vein
3.T-Bil>3.0mg/dL
4.History of interstitial pneumonitis
5.History of thromboembolism
6.Severe hypertention
7.Leukocytopenia or Thrombocytopenia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Murata |
Organization
Nippon medical school
Division name
Department of Radiology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
genji@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Murata |
Organization
Nippon medical school
Division name
Department of Radiology
Zip code
Address
Sendagi 1-1-5, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
genji@nms.ac.jp
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
Nippon medical school
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
| 2012 | Year | 03 | Month | 12 | 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
| 2012 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2012 | Year | 03 | Month | 12 | Day |
Last modified on
| 2014 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008778
