UMIN-CTR Clinical Trial

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
Email	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
Email	s.azuma@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041727