UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052641 |
|---|---|
| Receipt number | R000060072 |
| Scientific Title | Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2023/10/27 21:33:44 |
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Basic information
Public title
Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism
Acronym
Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism
Scientific Title
Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism
Scientific Title:Acronym
Establishment of a method for predicting therapeutic efficacy and adverse effects of drug therapy for hepatocellular carcinoma using tests related to the intestinal microbiota and elucidation of the mechanism
Region
| Japan |
Condition
Condition
Chronic Hepatitis, Hepatocellular Carcinoma, Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With the availability of ICIs, choosing the right treatment has become more crucial than ever. It's desirable to be able to predict the efficacy and adverse events before treatment, and necessary to select or change the treatment that suits the patient from multiple options. Recently, the changes in anti-tumor immunity and side effects caused by ICIs have drawn attention to the host's gut microbiota. However, explaining the efficacy and side effects solely based on the difference in microbial species is challenging. The presence or absence of increased intestinal permeability and individual differences therein could potentially lead to varying effects of gut bacteria and their metabolic products on the human body. There have been limited reports examining the relationship between the effectiveness and adverse events of drug treatment for HCC, including intestinal permeability and the gut environment, especially no reports from Japan yet. The main purpose of this study is to evaluate the impact of changes in gut bacteria and intestinal permeability on the effectiveness and adverse events of drug treatment for HCC.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In patients with hepatocellular carcinoma undergoing chemotherapy, identifying differences in gut microbiota and intestinal permeability between the groups with favorable treatment outcomes (where the response during administration is evaluated as stable disease (SD) or better, according to m-RECIST and RECIST criteria) and the groups with unfavorable outcomes (where the response during administration is evaluated as progressive disease (PD)).
Key secondary outcomes
Identification of gut microbiota and differences in intestinal permeability associated with adverse events during the treatment period.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 and over undergoing treatment for liver diseases including HCC at our institution
Patients with an ECOG Performance Status (PS) of 0-2
Consent obtained from the patient in writing
Key exclusion criteria
Patients with galactosemia
Patients who have experienced allergies to foods containing sugar alcohols
Patients with poorly controlled diabetes
Patients who wish to be excluded from the study
Patients who are pregnant, nursing, possibly pregnant or wish to become pregnant, or wishing to raise children
Other patients whom the physician has judged to be inappropriate for safely conducting this trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Honda |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8560, Japan
TEL
052-744-2169
honda@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Yamamoto |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2169
Homepage URL
kenta-y@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
The Nitto Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8560, Japan
Tel
052-744-2423
ethics@med.nagoya-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
| 2023 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060072
