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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033027
Receipt No. 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

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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
Email 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
Email apple-123-grape@ab.auone-net.jp

Sponsor
Institute Departments of Laboratory Medicine and Gastroenterology & Hepatology, Osaka General Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.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


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