UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037054 |
|---|---|
| Receipt number | 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 15:53:12 |
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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
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
chuma@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042222
