UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047777 |
|---|---|
| Receipt number | R000053982 |
| Scientific Title | Specific immune response in atezolizumab and bevacizumab |
| Date of disclosure of the study information | 2022/05/17 |
| Last modified on | 2022/05/17 01:25:00 |
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Basic information
Public title
Specific immune response in atezolizumab and bevacizumab
Acronym
Specific immune response in atezolizumab and bevacizumab
Scientific Title
Specific immune response in atezolizumab and bevacizumab
Scientific Title:Acronym
Specific immune response in atezolizumab and bevacizumab
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes of specific immune responses during atezolizumab plus bevacizumab therapy and the contributing factors affecting these changes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
enhancement of HCC specific anti-tumor immune responses
Key secondary outcomes
clinicopathological factors, progression-free survival, tumor response, overall survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with hepatocellular carcinoma treated with atezolizumab plus bevacizumab
2) with informed consent
Key exclusion criteria
1) patients refusal
2) inadequate patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eishiro |
| Middle name | |
| Last name | Mizukoshi |
Organization
Kanazawa University
Division name
Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2235
eishirom@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Terashima |
Organization
Kanazawa University
Division name
Advanced Preventive Medical Sciences Research Center
Zip code
920-8641
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2235
Homepage URL
tera@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kanazawa University
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
Tel
076-265-2110
rinri@adm.kanazawa-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
| 2022 | Year | 05 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 16 | 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
Immunological analyses will be performed using PBMCs and pathological specimens collected before and after combination therapy with atezolizumab and bevacizumab for hepatocellular carcinoma patients.
Management information
Registered date
| 2022 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053982
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
