UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032164 |
|---|---|
| Receipt number | R000036689 |
| Scientific Title | A study of biomarker predicting the effect of Nivolumab for unresectable advanced or recurrent gastric cancer. |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2024/10/13 18:34:58 |
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Basic information
Public title
A study of biomarker predicting the effect of Nivolumab for unresectable advanced or recurrent gastric cancer.
Acronym
Biomarker research of Nivolumab for gastic cancer.
Scientific Title
A study of biomarker predicting the effect of Nivolumab for unresectable advanced or recurrent gastric cancer.
Scientific Title:Acronym
Biomarker research of Nivolumab for gastic cancer.
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To search predictive biomarker of Nivolumab treatment for unresectable advanced or recurrent gastric cancer by immunohistochemical examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between overall survival (OS) and the protein expression of each factor.
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
1) Age over 20 years old.
2) Histologically diagnosed unresectable advanced or recurrent gastric or esophagogastric junction adenocarcinoma.
3) Tumor tissues for biomarker examination are available.
4) Treatment with more than 2 regimens is provided for unresectable advanced or recurrent gastric or esophagogastric cancer.
5) Nivolumab treatment is planning to go, is going, or was performed as a treatment with later than third rejimens.
6) Written informed consent.
Key exclusion criteria
1) Synchronous or metachronous (within 5 years) double cancers, except for intraepithelial tumor (Carcinoma in situ) or intramucosal tumor curatively resectable by local therapy at the time of Nivolumab treatment.
2) History of medical therapy for the purpose of the immune checkpoint inhibitors such as antiPD-1 antibody, antiPD-L1 antibody, antiCTLA-4 antibody or other T cell regulator before the Nivolumab treatment.
3) Having severe psychological illness and difficult to make a judgement for participation in the study.
4) Judged to be unfit to participate in the study by investigater.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Graduated School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Kurokawa |
Organization
Graduated School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
565-0871
Address
2-2-E2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3251
Homepage URL
ykurokawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
2-2-E2, Yamadaoka, Suita City, Osaka
Tel
06-6879-3251
thagi@gesurg.med.osaka-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
| 2018 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
https://doi.org/10.1038/s41416-020-0975-7
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1038/s41416-020-0975-7
Number of participants that the trial has enrolled
200
Results
The response rate was significantly higher in patients with performance status (PS) 0-1 (P=0.026), non-peritoneal metastasis (P=0.021), PD-L1 TPS>=1 (P=0.012), CPS>=5 (P=0.007) or>=10 (P<0.001) or MMR deficiency (P<0.001). Multivariate analysis revealed that CPS (P=0.001) and MMR (P=0.002) were independent prognostic factors of progression-free survival, as well as liver metastasis (P<0.001), peritoneal metastasis (P=0.004) and CRP (P<0.001).
Results date posted
| 2024 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 205 GC patients who were enrolled in this study, five were ineligible, for the following reasons: four did not receive nivolumab treatment and one demonstrated metachronous malignancy. Of the 200 patients who were eligible for study inclusion, 143 had measurable lesions, while 57 did not, and the proportions of patients with specific PD-L1 expression statuses were as follows: TPS>=1, 25.0%; CPS >=1, 58.5%; CPS>=5, 37.0%; CPS>=10, 19.5%. Of 200 patients, 21 (10.5%) showed negative MLH1 expression, 5 (2.5%) showed negative MSH2 expression, 4 (2.0%) showed negative MSH6 expression and 14 (7.0%) showed negative PMS2 expression. Overall, the proportion of patients who were MMR- deficient was 14.5%.
Participant flow
This cohort study included patients with unresectable or recurrent GC who had been treated or were scheduled to be treated with nivolumab as third-line or higher therapy between September 2017 and February 2019 at any of the 23 institutions of the Clinical Study Group of Osaka University, Upper Gastrointestinal Surgery Group. The eligibility criteria were as follows: histologically diagnosed with adenocarcinoma of the stomach or gastroesophageal junction, refractory or intolerant to two or more previous chemotherapy regimens, previous or anticipated treatment with nivolumab alone and 20 years of age or older. Patients who were previously treated with any immune-checkpoint inhibitor other than nivolumab were ineligible. Patients who had synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal carcinoma at the start of nivolumab treatment were excluded.
Adverse events
Not evaluated.
Outcome measures
https://doi.org/10.1038/s41416-020-0975-7
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2022 | 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
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036689
