UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047701 |
|---|---|
| Receipt number | R000054386 |
| Scientific Title | Exploratory biomarker study on tumor microenvironment using pre-treatment and refractory archival samples of hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/05/10 |
| Last modified on | 2022/05/10 17:00:43 |
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Basic information
Public title
Exploratory biomarker study on tumor microenvironment using pre-treatment and refractory archival samples of hepatocellular carcinoma
Acronym
Exploratory biomarker study on tumor microenvironment by archival samples of hepatocellular carcinoma
Scientific Title
Exploratory biomarker study on tumor microenvironment using pre-treatment and refractory archival samples of hepatocellular carcinoma
Scientific Title:Acronym
Exploratory biomarker study on tumor microenvironment by archival samples of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Unresectable hepatocellular carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using archival samples (tumor and non-tumor tissue samples, blood samples) of hepatocellular carcinoma patients who received atezolizumab plus bevacizumab or molecular targeted drugs (sorafenib, lenvatinib) in unresectable HCC first-line therapy, we will comprehensively analyze the clinical course and changes in tumor microenvironment and metabolic environment before and after drug treatment. By comparing clinical data such as treatment response, we will explore changes in the tumor microenvironment, including predictors of efficacy and mechanisms of drug resistance.
Basic objectives2
Others
Basic objectives -Others
Correlation of the efficacy of atezolizumab plus bevacizumab combination therapy to the tumor microenvironment and metabolic milieu and pre- and post-treatment changes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the efficacy of atezolizumab + bevacizumab combination therapy (response, early PD) and tumor microenvironment (PD-1 positive effector T cells, PD-1 positive regulatory T cells, CD36 positive regulatory T cells, angiogenesis and lymphangiogenesis) and metabolic environment (concentration of fatty acids etc.) and pre- and post-treatment changes.
Key secondary outcomes
Correlation between the efficacy and etiology of liver (metabolic environment), correlation between atezolizumab + bevacizumab combination therapy and the signature of oncogene expression and pre- and post-treatment changes.
Relation of the efficacy of the molecularly targeted agents lenvatinib and sorafenib to the tumor microenvironment and metabolic environment and pre- and post-treatment changes.
Relation between the efficacy of the molecularly targeted agents lenvatinib and sorafenib before and after treatment and the signatures of oncogene expression in the etiology of liver and changes in the metabolic environment.
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
Patients in clinical research approved by the Ethics Review Committee of the Graduate School of Medicine, Chiba University, who have given consent in opt-out form via an information disclosure document, who meet the following eligibility criteria, and who have secondary available archival samples (tumor/non-tumor tissue samples, blood samples).
1) Unresectable hepatocellular carcinoma
2) Receiving lenvatinib, sorafenib, or atezolizumab plus bevacizumab as first-line treatment (excluding hepatic arterial infusion or hepatic arterial chemoembolization)
Key exclusion criteria
Patients who do not meet the inclusion criteria.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Sadahisa |
| Middle name | |
| Last name | Ogasawara |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
TEL
043-222-7171
Homepage URL
kato.naoya@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
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
Chugai Pharmaceutical Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8677, JAPAN
Tel
043-222-7171
inohana-rinri@chiba-u.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 | 10 | 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 | 01 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients in clinical research approved by the Ethics Review Committee of the Graduate School of Medicine, Chiba University, who have given consent in opt-out form via an information disclosure document, who meet the following eligibility criteria, and who have secondary available archival samples (tumor/non-tumor tissue samples, blood samples).
1) Unresectable hepatocellular carcinoma
2) Receiving lenvatinib, sorafenib, or atezolizumab plus bevacizumab as first-line treatment (excluding hepatic arterial infusion or hepatic arterial chemoembolization)
Management information
Registered date
| 2022 | Year | 05 | Month | 10 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054386
