UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042218 |
|---|---|
| Receipt number | R000048189 |
| Scientific Title | The efficacy and safety of taxane therapy after discontinuation of nivolumab therapy in Japanese patients with advanced or recurrent esophageal cancer:a retrospective observational study (AFTER NIVO ESO Study) |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2023/01/12 17:24:46 |
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Basic information
Public title
The efficacy and safety of taxane therapy after discontinuation of nivolumab therapy in Japanese patients with advanced or recurrent esophageal cancer:a retrospective observational study (AFTER NIVO ESO Study)
Acronym
AFTER NIVO ESO study
Scientific Title
The efficacy and safety of taxane therapy after discontinuation of nivolumab therapy in Japanese patients with advanced or recurrent esophageal cancer:a retrospective observational study (AFTER NIVO ESO Study)
Scientific Title:Acronym
AFTER NIVO ESO study
Region
| Japan |
Condition
Condition
advanced or recurrent esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of taxanes administered as third-line therapy after discontinuation of nivolumab therapy with Japanese patients with advanced / recurrent esophageal cancer who received nivolumab in the ATTRACTION-3 (Clinical Trial Number: ONO-4538-24) study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate of taxanes administered as third-line therapy after nivolumab therapy
Key secondary outcomes
- PFS of taxanes after nivolumab
- OS of taxanes after nivolumab
- Tumor response rate of target lesions from the start to the end of taxanes treatment
- TTF from the start to the end of taxane treatment
- Safety of taxanes
- PFS from the start of nivolumab treatment to taxane treatment (PFS2)
- OS from the start of nivolumab treatment (OS2)
- Time from discontinuation of nivolumab treatment to start of taxane treatment (TFS)
- Efficacy and safety of taxanes in each subgroup
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
Japanese patients with advanced/recurrent esophageal cancer who received nivolumab in ATTRACTION-3 and a taxane in the 3rd-line treatment (Paclitaxel or docetaxel)
(Patients who started receiving a taxane as a third-line treatment by November 12, 2018)
Key exclusion criteria
Patients who withdrew consent before the analysis of this study
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical CO., LTD
Division name
Oncology Medical , Medical Affairs
Zip code
541-8564
Address
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL
06-6263-2992
hi.matsumoto@ono.co.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Kato |
Organization
EP-CRSU Co., Ltd
Division name
Clinical Business Operation Headquarters, Clinical Research Management Center
Zip code
541-0043
Address
King Osaka Bldg., 1-7 Toyotsucho, Suita-city, Osaka, Japan
TEL
06-7176-5731
Homepage URL
prj-after_niv@eps.co.jp
Sponsor or person
Institute
Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
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
Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel
06-6263-2992
n.nishiwaki@ono.co.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
| 2020 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10388-022-00972-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10388-022-00972-z
Number of participants that the trial has enrolled
75
Results
The ORR for taxanes after nivolumab was 29.6%, median PFS was 4.9 months, and median OS was 9.9 months. The ORR by taxane was 36.5% for paclitaxel, 12.5% for docetaxel, and 0.0% for DCF.Treatment-related adverse events with taxanes after nivolumab were observed in 87% of patients, of which 49% were Grade 3 -4, but there were no treatment-related deaths. There was no new signal compared to treatment-related adverse events with conventional taxanes.
Results date posted
| 2023 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 23 | Day |
Baseline Characteristics
Japanese patients enrolled in ATTRACTION-3 who received taxanes after nivolumab discontinuation
Participant flow
A retrospective analysis was performed in 75 patients from 28 study sites in Japan.
Adverse events
Treatment-related adverse events with taxanes after nivolumab were observed in 87% of patients, of which 49% were Grade 3 -4, but there were no treatment-related deaths. There was no new signal compared to treatment-related adverse events with conventional taxanes.
Outcome measures
Primary observation point : Overall response rate to taxanes
Secondary observation point: PFS, OS and Safety of taxanes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.
Management information
Registered date
| 2020 | Year | 10 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048189
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| Registered date | File name |
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