UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044924 |
|---|---|
| Receipt number | R000051311 |
| Scientific Title | Investigational study on immunomodulatory effect of lenvatinib in clinical specimens - Future oriented approach for lenvatinib on tumor microenvironment and cancer regression (FLORENCE) - |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2023/01/20 09:15:37 |
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Basic information
Public title
Investigational study on immunomodulatory effect of lenvatinib in clinical specimens - Future oriented approach for lenvatinib on tumor microenvironment and cancer regression (FLORENCE) -
Acronym
FLORENCE study
Scientific Title
Investigational study on immunomodulatory effect of lenvatinib in clinical specimens - Future oriented approach for lenvatinib on tumor microenvironment and cancer regression (FLORENCE) -
Scientific Title:Acronym
FLORENCE study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This is an exploratory study on immune-regulation by lenvatinib by using archived specimen in
Hiroshima University.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the immuno-stimulatory effect of lenvatinib and the change of immune system through lenvatinib treatment using tumor samples by identifying immune cell profiling in tumor tissue before and after lenvatinib treatment
Key secondary outcomes
Progression-free survival, Overall survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in this study have advanced hepatocellular carcinoma and administered lenvatinib as first line treatment in Hiroshima university hospital. All patients in this study provide written informed consent. The details of inclusion and exclusion criteria are written in the following section.
Key exclusion criteria
Lenvatinib was administered after second-line therapy
Informed consent for analysis was withdrawn
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuaki |
| Middle name | |
| Last name | Chayama |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology and Metabolism
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
0822575190
chayama@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Yamauchi |
Organization
Hiroshima University Hospital
Division name
Department of Clinical Oncology
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
0822575193
Homepage URL
myamauchi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee, Hiroshima University Hospital
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
Tel
0822571576
iryo-seisaku@office.hiroshima-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
| 2021 | Year | 07 | Month | 20 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051311
