UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043934 |
|---|---|
| Receipt number | R000049965 |
| Scientific Title | Efficacy and involvement gut microbiota of atezolizumab plus bevacizumab therapy in patients with hepatocellular carcinoma. |
| Date of disclosure of the study information | 2021/04/15 |
| Last modified on | 2024/04/17 10:54:51 |
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Basic information
Public title
Efficacy and involvement gut microbiota of atezolizumab plus bevacizumab therapy in patients with hepatocellular carcinoma.
Acronym
Efficacy and involvement gut microbiota of atezolizumab plus bevacizumab therapy in patients with hepatocellular carcinoma.
Scientific Title
Efficacy and involvement gut microbiota of atezolizumab plus bevacizumab therapy in patients with hepatocellular carcinoma.
Scientific Title:Acronym
Efficacy and involvement gut microbiota of atezolizumab plus bevacizumab therapy in patients with hepatocellular carcinoma.
Region
| Japan |
Condition
Condition
Unresectable advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the correlation between the efficacy of agents approved for the treatment of advanced hepatocellular carcinoma (atezolizumab plus bevacizumab therapy) and the gut microbiota. And we aim to identify predictors of therapeutic efficacy by analyzing the gut microbiota and cytokines and chemokines in the feces of patients with unresectable advanced hepatocellular carcinoma. The other is to determine how the gut microbiota influences tumor immunity.
Basic objectives2
Others
Basic objectives -Others
We will investigate the correlation between adverse events and gut microbiota in atezolizumab and bevacizumab therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association with gut microbiota composition and efficacy of atezolizumab and bevacizumab therapy in patients with unresectable advanced hepatocellular carcinoma.
Key secondary outcomes
Incidence of adverse events, concentration of cytokines and chemokines in the blood, and ratio of tumor immune-related cells in the blood.
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. Patients with unresectable advanced hepatocellular carcinoma
2. Patients who have not received any prior systemic therapy
3. Patients whose physician has suggested and agreed to atezolizumab plus bevacizumab as the optimal treatment
Key exclusion criteria
1. Patients with impaired liver reserve (Child-Pugh class C)
2. Patients with refractory ascites
3. Patients judged ineligible by the principal investigator and sub-investigators
4. Patients for whom local therapy is indicated
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Torimura |
Organization
Kurume university
Division name
Gastroenterology
Zip code
830-0011
Address
67 Asahimachi, Kurume City, Fukuoka Prefecture
TEL
0942-31-7561
tori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomotake |
| Middle name | |
| Last name | Shirono |
Organization
Kurume university
Division name
Gastroenterology
Zip code
830-0011
Address
67 Asahimachi, Kurume City, Fukuoka Prefecture
TEL
0942-31-7561
Homepage URL
shirono_tomotake@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume university
Institute
Department
Personal name
Funding Source
Organization
There is no funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakult Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume university
Address
67 Asahimachi, Kurume City, Fukuoka Prefecture
Tel
0942-35-3311
i_rinri@kurume-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
| 2021 | Year | 04 | Month | 15 | 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
34
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Date analysis in progress.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | 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
The purpose of this study is to analyze the gut microbiota in the feces of human hepatocellular carcinoma patients and the cytokines and chemokines induced by the gut microbiota. Also, to examine the correlation between the gut microbiota and the efficacy of treatment (atezolizumab and bevacizumab combination therapy) in patients with unresectable advanced hepatocellular carcinoma, to identify predictors of treatment efficacy, and to determine how gut microbiota influences tumor immunity. In addition, this study will examine the association of gut microbiota with adverse reactions to atezolizumab and bevacizumab combination therapy.
Management information
Registered date
| 2021 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049965
