UMIN-CTR Clinical Trial

Basic information
Public title	The study of efficacy of lenvatinib in patients with hepatocellular carcinoma(HCC): Multicenter analysis.
Acronym	The study of efficacy of lenvatinib in patients with hepatocellular carcinoma(HCC): Multicenter analysis.
Scientific Title	The study of efficacy of lenvatinib in patients with hepatocellular carcinoma(HCC): Multicenter analysis.
Scientific Title:Acronym	The study of efficacy of lenvatinib in patients with hepatocellular carcinoma(HCC): Multicenter analysis.
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to investigate the prognostic and predictive factors of lenvatinib in patients with HCC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	OS
Key secondary outcomes	PFS OR/DCR Safety

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)At least 20 years old when consent is given 2)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma found to be ineligible for resection or local treatment 3)Lesions measurable with contrast-enhanced CT or contrast-enhanced MRI 4)Child-Pugh class A or B 5)ECOG performance status (PS) of 0 or 1 6) Adequate functional reserve of major organs 7)Capable of complying with requirements about visit days, medication, and laboratory tests 8)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Key exclusion criteria	1)Clinically significant ascites (refractory ascites requiring drainage) 2)Esophageal varices with the potential to bleed 4)Brain tumor 5)On dialysis 6)Gastrointestinal hemorrhage during past month 7)Active multiple cancer 8)Any of the following concurrent diseases: Grade 3 or greater arrhythmia or poorly controlled hypertension according to the JCOG/JSCO Japanese translation of the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE v 4.0) 9)Orally taking an herbal medicine approved for the treatment of cancer (e.g., shosaikoto) 10)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related disease 11) Pregnant or nursing 12) Otherwise found ineligible as a subject by the researcher
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Makoto Last name Chuma
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	Yokohama
TEL	045-261-5656
Email	chuma@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Chuma
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	Yokohama
TEL	045-261-5656
Homepage URL
Email	chuma@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	Yokohama City University 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	YCU Center for Novel and Exploratory Clinical Trials
Address	1-1-1, Fukuura, Kanazawa-ku, Yokohama
Tel	045-370-7991
Email	nextjim1@yokohama-cu.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 06 Month 13 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 05 Month 01 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	retrospective observational study

Management information
Registered date	2019 Year 06 Month 13 Day
Last modified on	2019 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042222