UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029648 |
|---|---|
| Receipt number | R000033676 |
| Scientific Title | Portal hemodynamic effects of regorafenib in patients with advanced hepatocellular carcinoma: a prospective cohort study |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2020/04/26 11:25:45 |
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Basic information
Public title
Portal hemodynamic effects of regorafenib in patients with advanced hepatocellular carcinoma: a prospective cohort study
Acronym
Portal hemodynamic effects of regorafenib
Scientific Title
Portal hemodynamic effects of regorafenib in patients with advanced hepatocellular carcinoma: a prospective cohort study
Scientific Title:Acronym
Portal hemodynamic effects of regorafenib
Region
| Japan |
Condition
Condition
patients with advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the portal hemodynamic effect of regorafenib in patients with advanced HCC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in portal venous area
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
Regorafenib 160 mg per day for 2 weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Advanced-stage HCC is confirmed by radiological analysis. Patients were classified as having advanced-stage HCC if they were not eligible for or had disease progression after surgical or locoregional therapies.
Key exclusion criteria
Tumor invasion in intrahepatic large vessels was classified according to the criteria of the Liver Cancer Study of Japan as portal tumor invasion involving first-order-branches (Vp3) and the main trunk of the portal vein (Vp4), or as tumor invasion involving first-order branches of the hepatic vein (Vv2) and the inferior vena cava (Vv3).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | HIDAKA |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology, Internal Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0380, Japan
TEL
+81-42-778-7750
hisashi7@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | HIDAKA |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology, Internal Medicine
Zip code
252-0380
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0380, Japan
TEL
+81-42-778-7750
Homepage URL
hisashi7@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine
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
Kitasato University ethical communiity
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0380, Japan
Tel
+81-42-778-8111
rinri@med.kitasato-u.ac.jp
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
| 2017 | Year | 11 | 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
3
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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 21 | Day |
Last modified on
| 2020 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033676
| 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 |
