UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050925 |
|---|---|
| Receipt number | R000057990 |
| Scientific Title | An observational study of the safety and efficacy of nivolumab as adjuvant treatment for esophageal cancer using the Comprehensive Registry of Esophageal Cancer in the National Clinical Database. |
| Date of disclosure of the study information | 2023/04/25 |
| Last modified on | 2025/04/27 11:05:25 |
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Basic information
Public title
An observational study of the safety and efficacy of nivolumab as adjuvant treatment for esophageal cancer using the Comprehensive Registry of Esophageal Cancer in the National Clinical Database.
Acronym
An observational study of the safety and efficacy of adjuvant nivolumab therapy for esophageal cancer.
Scientific Title
An observational study of the safety and efficacy of nivolumab as adjuvant treatment for esophageal cancer using the Comprehensive Registry of Esophageal Cancer in the National Clinical Database.
Scientific Title:Acronym
An observational study of the safety and efficacy of adjuvant nivolumab therapy for esophageal cancer.
Region
| Japan |
Condition
Condition
Esophageal cancer or esophagogastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of adjuvant nivolumab therapy versus no therapy in patients with resected esophageal cancer treated with neoadjuvant therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Incidence rate of Grade 2 or higher adverse events of endocrine or judged to be immune-related among patients receiving adjuvant nivolumab therapy.
2 2-year recurrence-free survival rate: The recurrence-free survival rate at 2 years after the surgery, estimated by the Kaplan-Meier method, where the starting point is the date of surgery, the event is the cancer recurrence, and the censoring date is the last date when recurrence-free survival is confirmed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric junction following preoperative adjuvant therapy (chemotherapy or chemoradiotherapy) with R0 resection who first visited an authorized Institutes for Board Certified Esophageal Surgeons in 2023 and have not achieved a pathologic complete response to preoperative therapy.(Cases initially diagnosed in 2022 and operated on in 2023 will not be included, but cases initially diagnosed in 2023 and operated on in 2024 will be included.)
Key exclusion criteria
Cases of esophageal cancer other than squamous cell carcinoma or adenocarcinoma, have not been treated with neoadjuvant therapy, and that resulted in R1 or R2 resection.
Target sample size
1750
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Cancer Institute Hospital of Japanese Foundation For Cancer Research
Division name
Division of esophageal surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
0335200111
masayuki.watanabe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kanamori |
Organization
Cancer Institute Hospital of Japanese Foundation For Cancer Research
Division name
Division of esophageal surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL
0335200111
Homepage URL
jun.kanamori@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation For Cancer Research
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Bristol-Myers Squibb K.K.
IRB Contact (For public release)
Organization
Medical Research Ethics Review Board of Japanese Foundation For Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
Tel
0335200111
med.shinsa@jfcr.or.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 | 04 | Month | 25 | 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
1842
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoints
1 Incidence of Grade 2 or higher endocrine disruptions and adverse events judged to be immune-related in patients treated with adjuvant nivolumab.
2 2 year relapse-free survival rate
2-year recurrence-free survival rate: The recurrence-free survival rate at 2 years is estimated by the Kaplan-Meier method, where the starting point is the date of surgery, the event is the recurrence, and the censoring date is the last date of confirmed recurrence-free survival.
Secondary endpoints:
Percentage of patients who completed planned treatment with adjuvant nivolumab, percentage who were able to continue treatment up to 1 year postoperatively, percentage of permanent adverse events related to nivolumab, and percentage of nonendocrine Grade 3 or higher adverse events.
Management information
Registered date
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057990
