UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036625 |
|---|---|
| Receipt number | R000041727 |
| Scientific Title | Prognostic and predictive factors of lenvatinib in patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2019/04/29 |
| Last modified on | 2020/10/29 17:59:38 |
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Basic information
Public title
Prognostic and predictive factors of lenvatinib in patients with hepatocellular carcinoma
Acronym
Prognostic and predictive factors of lenvatinib in patients with hepatocellular carcinoma
Scientific Title
Prognostic and predictive factors of lenvatinib in patients with hepatocellular carcinoma
Scientific Title:Acronym
Prognostic and predictive factors of lenvatinib in patients with hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Others
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
PFS between 2 groups of eNOS HT1/HT1 group and Other group (HT1; the allele T at eNOS-786 and allele 4b at eNOS VNTR)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Past history, cases judged to be hepatocellular carcinoma by blood test and diagnostic imaging
2) Unresectable progressive / recurrent cases
3) Orally administrable cases; excluding cases of upper gastrointestinal dysfunction or cases of malabsorption syndrome that affect the absorption of lenvatinib
4) Cases that are 0-2 in the criteria of ECOG PS (PS must be included in medical records)
5) Cases in which one or more lesions that can be evaluated by mRECIST have been confirmed by objective data such as CT, MRI, and X-ray examination within 28 days before registration (not including the date of registration)
6) Cases without prior history of lenvatinib treatment including treatment for other carcinomas
7) Cases with sufficient organ function
8) Patients who are expected to survive at least 3 months from the date of registration
9) Cases in which consent was obtained in writing from the study subject
Key exclusion criteria
1) Cases with a history of hypersensitivity to the ingredients of this drug
2) Patients who have been treated with other molecule-targeted drugs
3) Women who are pregnant, have a possibility of becoming pregnant, fall within 28 days postpartum, or breastfeeding. A man who wants a partner's pregnancy.
4) A case in which a mental illness or mental disorder that interferes with daily life is included and it is judged that participation in research is difficult
5) Cases judged as inappropriate for this study by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | HISASHI |
| Middle name | |
| Last name | HIDAKA |
Organization
Kitasato University Hospital
Division name
Department of gastroenterology
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
TEL
042-778-8111
hisashi7@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | SHINTARO |
| Middle name | |
| Last name | AZUMA |
Organization
Kitasato University Hospital
Division name
Department of pharmacy
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
TEL
042-778-8111
Homepage URL
s.azuma@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
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
The Kitasato Institute, Clinical Research Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
Tel
042-778-8111
rinri-n@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
| 2019 | Year | 04 | Month | 29 | 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
100
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
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
gene expression analysis
Management information
Registered date
| 2019 | Year | 04 | Month | 29 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041727
