UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034333 |
|---|---|
| Receipt number | R000039145 |
| Scientific Title | The safety and efficacy of Lenvatinib for patients with unresectable hepatocellular carcinoma on practical medicine after the approval |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2022/04/04 15:08:33 |
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Basic information
Public title
The safety and efficacy of Lenvatinib for patients with unresectable hepatocellular carcinoma on practical medicine after the approval
Acronym
The safety and efficacy Lenvatinib on practical medicine
Scientific Title
The safety and efficacy of Lenvatinib for patients with unresectable hepatocellular carcinoma on practical medicine after the approval
Scientific Title:Acronym
The safety and efficacy Lenvatinib on practical medicine
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety and efficacy of Lenvatinib on practical medicine and to compare with the results and the REFLECT trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Objective response rate
Adverse events
Drug withdrawal
Drug interruption
Dose reduction
Dose intensity
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
unresectable hepatocellular carcinoma
Key exclusion criteria
Pregnant woman
Woman who may be pregnant
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Katsushima |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Gastroenterology
Zip code
6128555
Address
Fukakusa-mukaibatakechou 1-1, Fushimi-ku, Kyoto, JAPAN
TEL
075-641-9161
katsushima.shinji.ky@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Katsushima |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Gastroenterology
Zip code
6128555
Address
Fukakusa-mukaibatakechou 1-1, Fushimi-ku, Kyoto, JAPAN
TEL
075-641-9161
Homepage URL
katsushima.shinji.ky@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, National Hospital Organization Kyoto Medical Center
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
Kyoto Medical Center IRB
Address
Fukakusa-mukaibatakechou 1-1, Fushimi-ku, Kyoto, JAPAN
Tel
075-641-9161
404-shoukaki@mail.hosp.go.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 | 01 | 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
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
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | 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
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Overall survival are measured from the date of the initiation of Lenvatinib until the date of death from any cause.
Tumor assessments are down every 8weeks using dynamic CT or dynamic MRI.
Adverse events are graded according to CTCAE version 4.0.
Management information
Registered date
| 2018 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039145
