UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034805 |
|---|---|
| Receipt number | R000039694 |
| Scientific Title | An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2018/11/07 |
| Last modified on | 2022/11/14 08:24:30 |
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Basic information
Public title
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Acronym
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Scientific Title
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Scientific Title:Acronym
An Investigation of the relationship between adverse event and efficacy of treatment with lenvatinib in patients with unresectable hepatocellular carcinoma
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this prospective study is to evaluate the efficacy of treatment with lenvatinib in patients with unresectable advanced HCC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy
Key secondary outcomes
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
1)Histologically or clinically (imaging and tumor markers) diagnosed hepatocellular carcinoma
2)Not eligible for local treatment (e.g., surgery, RFA, TAE, and ethanol injection)
3)Lesions evaluable with contrast-enhanced computed tomography (CT) or contrast- enhanced magnetic resonance imaging (MRI)
4)No carryover of effects or adverse effects of prior treatmen
5)Child-Pugh Score 5-8
6)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7)Adequate functional reserve of major organs
8)Patients with systolic blood pressure of 140 mmHg or less and diastolic blood pressure of 90 mmHg or less
9)Over 20 years old
10) Capable of complying with requirements with respect to visit days, medication, and laboratory tests
11)The patient provides written informed consent before the start of the clinical study
Key exclusion criteria
1)Clinically significant ascites (i.e., refractory ascites requiring drainage)
2)History of liver transplantation
3)Esophageal varices with the potential to bleed
4)Concurrent or prior hepatic encephalopathy
5)Brain tumor
6)Currently on dialysis
7)Active double cancer
8)Orally taking an herbal medicine approved for the treatment of cancer (e.g., sho-saiko-to)
9)Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) -related disease
10)Pregnant or nursing
11)Otherwise found by the investigator or subinvestigator to be ineligible as a subject
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Akutsu |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
0608543
Address
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
akutsu@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Akutsu |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
0608543
Address
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
akutsu@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Sapporo medical university
Address
S1 W17, Chuo-ku, Sapporo, 060-8556, Japan
Tel
011-611-2111
ji-rskk@sapmed.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
| 2018 | Year | 11 | Month | 07 | 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
| 2018 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2018 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039694
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