Esophageal CancerNCT06499298
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer
An observational study of Esophageal Cancer and Gastroesophageal Junction Cancer, run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- Nivolumab
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 16 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult participants from China with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) who initiated nivolumab treatment in routine clinical practice between June 27, 2022 and October 31, 2023.
Who may be able to join
- Participants aged 18 years or older at the index date
- All patients must have Stage II or Stage III carcinoma of the esophagus or gastroesophageal junction and have histologically or cytologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis.
- Participants initiated nivolumab in adjuvant Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) treatment within the index window.
Who cannot join
- Participation in a clinical trial of an investigational drug concurrently during the adjuvant nivolumab treatment.
- From the date of diagnosis of EC or GJEC to data end period, patients were diagnosed with a primary diagnosis of a cancer other than EC or GJEC that requires systemic or other treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China
The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China.
- Being tested
- Nivolumab
- Keywords
- Esophageal Cancer (EC), Gastroesophageal Junction Cancer (GEJC)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
As per product label, as prescribed by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving adjuvant nivolumab | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant disease-free survival (DFS)
Measured: Up to 1 year
Secondary outcomes (26)
Participant socio-demographics
Measured: Baseline and up to 1 year
Date of tumor initial diagnosis
Measured: Baseline
Tumor location at initial diagnosis
Measured: Baseline
Tumor histology at initial diagnosis
Measured: Baseline
Resected tumor margins status
Negative (clear), positive (involved), close margins
Measured: Baseline
Eastern Cooperative Oncology Group (ECOG) performance status
Measured: Baseline and up to 1 year
Pathological lymph-node status
Measured: Baseline and up to 1 year
Pathological tumor status
Measured: Baseline and up to 1 year
Participant biomarkers (if available)
Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis
Measured: Baseline and up to 1 year
Participant outcomes after nivolumab treatment
Including disease stage, recurrence, disease progression, medical imaging test result, and death information
Measured: Baseline and up to 1 year
Participant medical history
Measured: Baseline and up to 1 year
Participant cancer treatment history
Measured: Baseline
Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation
Measured: Day 1
Indication for nivolumab treatment
Measured: Day 1
Nivolumab treatment duration
Measured: Up to 1 year
Time from surgery to nivolumab initiation
Measured: Day 1
Nivolumab treatment regimen
Measured: Up to 1 year
Participant concomitant treatment(s)
Measured: Baseline and up to 1 year
Participant systemic treatment(s)
Measured: Up to 1 year
Date of nivolumab treatment completion/discontinuation
Measured: Up to 1 year
Reasons for treatment discontinuation/cessation
Measured: Up to 1 year
Subsequent treatment after nivolumab discontinuation
Measured: Up to 1 year
Time to next treatment (TTNT)
Measured: Up to 1 year
Nivolumab treatment modifications in relation to the management of adverse events (AE)
Measured: Up to 1 year
Participant distant metastasis-free survival (DMFS)
Measured: Up to 1 year
Participant distant metastasis-free survival (DMFS) rates
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start3 Dec 2024
- Primary completion16 Apr 2025
- Study completion16 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499298
- Sponsor's protocol ID
- CA209-1428
- Status last verified
- May 2025
- First submitted
- 21 Jun 2024
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China
- ClinicalTrials.gov ID
- NCT06499298
- Acronym / sponsor ID
- CA209-1428
- Keywords
- Esophageal Cancer (EC), Gastroesophageal Junction Cancer (GEJC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the real-world effectiveness and patterns of use of adjuvant nivolumab in adult participants with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving adjuvant nivolumab | – | Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult participants from China with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) who initiated nivolumab treatment in routine clinical practice between June 27, 2022 and October 31, 2023.
Key inclusion criteria (3 listed)
- Participants aged 18 years or older at the index date
- All patients must have Stage II or Stage III carcinoma of the esophagus or gastroesophageal junction and have histologically or cytologically confirmed predominant adenocarcinoma or squamous cell carcinoma esophageal or gastroesophageal junction cancer at the time of initial diagnosis.
- Participants initiated nivolumab in adjuvant Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) treatment within the index window.
Key exclusion criteria (2 listed)
- Participation in a clinical trial of an investigational drug concurrently during the adjuvant nivolumab treatment.
- From the date of diagnosis of EC or GJEC to data end period, patients were diagnosed with a primary diagnosis of a cancer other than EC or GJEC that requires systemic or other treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAs per product label, as prescribed by treating physician | Drug | Participants receiving adjuvant nivolumab |
Primary outcome
Participant disease-free survival (DFS)
Time frame: Up to 1 year
26 secondary outcomes
Participant socio-demographics
Time frame: Baseline and up to 1 year
Date of tumor initial diagnosis
Time frame: Baseline
Tumor location at initial diagnosis
Time frame: Baseline
Tumor histology at initial diagnosis
Time frame: Baseline
Resected tumor margins status
Time frame: Baseline
Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Baseline and up to 1 year
Pathological lymph-node status
Time frame: Baseline and up to 1 year
Pathological tumor status
Time frame: Baseline and up to 1 year
Participant biomarkers (if available)
Time frame: Baseline and up to 1 year
Participant outcomes after nivolumab treatment
Time frame: Baseline and up to 1 year
Participant medical history
Time frame: Baseline and up to 1 year
Participant cancer treatment history
Time frame: Baseline
Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation
Time frame: Day 1
Indication for nivolumab treatment
Time frame: Day 1
Nivolumab treatment duration
Time frame: Up to 1 year
Time from surgery to nivolumab initiation
Time frame: Day 1
Nivolumab treatment regimen
Time frame: Up to 1 year
Participant concomitant treatment(s)
Time frame: Baseline and up to 1 year
Participant systemic treatment(s)
Time frame: Up to 1 year
Date of nivolumab treatment completion/discontinuation
Time frame: Up to 1 year
Reasons for treatment discontinuation/cessation
Time frame: Up to 1 year
Subsequent treatment after nivolumab discontinuation
Time frame: Up to 1 year
Time to next treatment (TTNT)
Time frame: Up to 1 year
Nivolumab treatment modifications in relation to the management of adverse events (AE)
Time frame: Up to 1 year
Participant distant metastasis-free survival (DMFS)
Time frame: Up to 1 year
Participant distant metastasis-free survival (DMFS) rates
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastroesophageal Junction Cancer, run by Bristol-Myers Squibb at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant disease-free survival (DFS) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.