UMIN-CTR Clinical Trial

Basic information
Public title	Correlation between mass of muscle and effect of lenvatinib in patients with hepatocellular carcinoma
Acronym	Correlation between mass of muscle and effect of lenvatinib
Scientific Title	Correlation between mass of muscle and effect of lenvatinib in patients with hepatocellular carcinoma
Scientific Title:Acronym	Correlation between mass of muscle and effect of lenvatinib
Region	Japan

Condition
Condition	hepatocellular carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate if body skeletal muscle mass were correlated with toxicity and survival in patients with advanced HCC treated with lenvatinib.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The influences of SMI on the occurrence of drug withdral due to severe adverse events (AEs).
Key secondary outcomes	We also investigated the influences of SMI on TTF (Time to treatment failure) and Overall survival(OS).

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 with unresectable HCC and the following features: i) The presence of distant metastases; ii) refractory response to previous transcatheter arterial therapies for HCC; iii) unsuitability for transcatheter arterial therapies due to anatomical reasons; iv) vascular invasion such as tumor thrombus in the portal vein.
Key exclusion criteria	i) child-pugh class C, ii) poorly controlled ascites, iii) severe renal dysfunction iv) malignancy except hepatocellular carcinoma
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Haruki Middle name Last name Uojma
Organization	Kitasato University school of medicine
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	kiruha@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Haruki Middle name Last name Uojima
Organization	Kitasato University school of medicine
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
Homepage URL
Email	kiruha@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University school of medicine
Institute
Department

Funding Source
Organization	Kitasato University school of medicine
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	Kitasato University school of medicine, Institutional Review Board
Address	1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0375, Japan
Tel	042-778-8111
Email	rinrib@med.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 07 Month 15 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	2019 Year 05 Month 08 Day
Date of IRB	2019 Year 05 Month 18 Day
Anticipated trial start date	2019 Year 05 Month 18 Day
Last follow-up date	2022 Year 01 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information	retrospective study

Management information
Registered date	2019 Year 07 Month 15 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042596