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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037054
Receipt No. R000042222
Scientific Title The study of efficacy of lenvatinib in patients with hepatocellular carcinoma(HCC): Multicenter analysis.
Date of disclosure of the study information 2019/06/13
Last modified on 2019/06/13

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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

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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