UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057676 |
|---|---|
| Receipt number | R000065888 |
| Scientific Title | The observational study of gut or oral MIcrobiota during chemotherapY plus nivolumab And interaction of concomiTAnt mediCations for advanced gasTric cancer |
| Date of disclosure of the study information | 2025/04/22 |
| Last modified on | 2025/04/22 10:45:36 |
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Basic information
Public title
The observational study of gut or oral MIcrobiota during chemotherapY plus nivolumab And interaction of concomiTAnt mediCations for advanced gasTric cancer
Acronym
MIYATACT study
Scientific Title
The observational study of gut or oral MIcrobiota during chemotherapY plus nivolumab And interaction of concomiTAnt mediCations for advanced gasTric cancer
Scientific Title:Acronym
MIYATACT study
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the treatment outcomes of nivolumab combined chemotherapy for unresectable/advanced gastric cancer in daily clinical practice. To exploratory study the effects of oral and intestinal flora and combined drugs including probiotics on the treatment outcomes of nivolumab combined chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
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
Prospective cohort:
Confirmed by pathological examination to have primary adenocarcinoma of the stomach or gastroesophageal junction.
Diagnosed with unresectable or advanced recurrent gastric cancer.
Scheduled to receive triple therapy of nivolumab, S1 or capecitabine or fluorouracil, and oxaliplatin between the
date of implementation approval and June 30, 2026.
Patients for which no prior treatment for unresectable advanced or recurrent gastric cancer has been performed. However, cases that underwent perioperative chemotherapy may be enrolled if recurrence is confirmed 6 months or more after the end of perioperative chemotherapy.
Stool or saliva can be collected.
Retrospective cohort:
Patients who underwent nivolumab combination chemotherapy after November 2021, and who have already started nivolumab combination chemotherapy at the time of enrollment. Patients who have been treated with a triple combination of nivolumab, S1 or capecitabine or fluorouracil, and oxaliplatin, but have discontinued one or two drugs due to adverse events, etc. are also eligible. Both ongoing and completed cases can be enrolled. Patients who have been treated with systemic chemotherapy with fluoropyrimidine drugs and oxaliplatin first and then with nivolumab from the second course are also eligible.
Diagnosed with unresectable or advanced recurrent gastric cancer.
ECOG PS 0 to 2
Patients have not undergone prior treatment for unresectable advanced or recurrent gastric cancer before nivolumab combination chemotherapy. However, patients who have undergone perioperative chemotherapy can be enrolled if recurrence is observed 6 months or more after the end of perioperative chemotherapy.
The subject is given the opportunity to refuse study participation through the publication of an optout notice, etc., and does not express an intention to refuse.
Key exclusion criteria
Prospective cohort:
HER2 positive cases
Active multiple cancers.
Fluid retention requiring drainage within 2 weeks prior to enrollment.
Pulmonary fibrosis or interstitial pneumonia.
Severe complications.
Active infections.
Active viral hepatitis.
Poorly controlled diabetes.
Clinically significant psychiatric or central nervous system disorders.
Severe electrocardiogram abnormalities or clinically significant cardiac disease.
Clinically suspected brain or cerebrospinal membrane metastases.
Pregnant or lactating women, or men or women who do not use appropriate contraception.
Nivolumab administration is contraindicated.
Require continuous oral administration of steroids at a dose of 10mg per day or more in prednisolone equivalent.
The attending physician judged to be inappropriate for participation in this study.
Retrospective cohort:
HER2 positive cases
Patients had undergone two or more courses of systemic chemotherapy with fluoropyrimidine drugs and oxaliplatin for unresectable advanced or recurrent gastric cancer.
Active secondary cancers.
Body cavity fluid collection requiring drainage within 2 weeks.
Pulmonary fibrosis or interstitial pneumonia.
Serious complications.
Active infections.
Active viral hepatitis.
Poorly controlled diabetes mellitus.
Clinically significant psychiatric disorders or central nervous system disorders.
Severe electrocardiogram abnormalities or clinically significant cardiac diseases.
Clinically suspected brain metastasis or cerebrospinal membrane metastasis.
Require continuous oral administration of steroids at a dose of 10 mg per day or more in prednisolone equivalent.
The attending physician judges to be inappropriate to participate in this study.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Divison of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido
TEL
0117161161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Harada |
Organization
Hokkaido university hospital
Division name
Divison of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido
TEL
0117161161
Homepage URL
haraharaccho0605@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Gastrointestinal Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Gastrointestinal Cancer Study Group
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
Crjimu@huhp.hokudai.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
北海道大学病院(北海道)、富山大学附属病院（富山県）、釧路労災病院(北海道)、
市立函館病院(北海道)、市立札幌病院(北海道)、 KKR札幌医療センター(北海道)、国立病院機構北海道医療センター(北海道)、市立稚内病院(北海道)、NTT東日本札幌病院(北海道)、岩見沢市立総合病院(北海道)、苫小牧市立病院(北海道)、北見赤十字病院(北海道)、北海道消化器科病院(北海道)、長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the treatment outcomes of nivolumab combined chemotherapy in patients with advanced gastric cancer in daily clinical practice, and to explore the effects of oral and intestinal bacterial flora and combined drugs on treatment outcomes
Management information
Registered date
| 2025 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065888
