UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033027 |
|---|---|
| Receipt number | R000037652 |
| Scientific Title | Efficacy and safety of vitamin K + lenvatinib combination treatment against hepatocellular carcinoma:a randomised,open label,phase 2 trial |
| Date of disclosure of the study information | 2018/06/17 |
| Last modified on | 2018/06/17 15:12:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of vitamin K + lenvatinib combination treatment against hepatocellular carcinoma:a randomised,open label,phase 2 trial
Acronym
Vitamin K + lenvatinib combination treatment against HCC
Scientific Title
Efficacy and safety of vitamin K + lenvatinib combination treatment against hepatocellular carcinoma:a randomised,open label,phase 2 trial
Scientific Title:Acronym
Vitamin K + lenvatinib combination treatment against HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the enhanced anti-cancer action of lenvatinib by vitamin K combination against advanced hepatocellular carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival(evaluated by modified RECIST)
Key secondary outcomes
overall survival
safety (comparison in adverse event incidence)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
lenvatinib(12mg or 8mg, daily) alone treatment, continued if neither severe adverse events nor disease progression is seen
Interventions/Control_2
lenvatinib(12mg or 8mg, daily)+vitamin K(45mg, daily) combination treatment, continued if neither severe adverse events nor disease progression is seen
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ECOG performance status: 0 or 1
Child-Pugh score: 8 or less
suffering with osteoporosis
Written consent is obtained.
Key exclusion criteria
dosed with warfarin
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Haruna |
Organization
Osaka General Medical Center
Division name
Departments of Laboratory Medicine and Gastroenterology & Hepatology
Zip code
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka 558-8558, Japan
TEL
06-6692-1201
apple-123-grape@ab.auone-net.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimichi Haruna |
Organization
Osaka General Medical Center
Division name
Departments of Laboratory Medicine and Gastroenterology & Hepatology
Zip code
Address
3-1-56 Bandaihigashi, Sumiyoshiku, Osaka 558-8558, Japan
TEL
06-6692-1201
Homepage URL
apple-123-grape@ab.auone-net.jp
Sponsor or person
Institute
Departments of Laboratory Medicine and Gastroenterology & Hepatology, Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Departments of Laboratory Medicine and Gastroenterology & Hepatology, Osaka General 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
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
| 2018 | Year | 06 | Month | 17 | 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
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 17 | 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
| 2018 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037652
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
