Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer

May 30, 2025 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: +1855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • China
      • Shanghai, China, 200030
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants receiving adjuvant nivolumab
Drug: Nivolumab
As per product label, as prescribed by treating physician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Participant disease-free survival (DFS)
Time Frame: Up to 1 year
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant socio-demographics
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Date of tumor initial diagnosis
Time Frame: Baseline
Baseline
Tumor location at initial diagnosis
Time Frame: Baseline
Baseline
Tumor histology at initial diagnosis
Time Frame: Baseline
Baseline
Resected tumor margins status
Time Frame: Baseline
Negative (clear), positive (involved), close margins
Baseline
Eastern Cooperative Oncology Group (ECOG) performance status
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Pathological lymph-node status
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Pathological tumor status
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Participant biomarkers (if available)
Time Frame: Baseline and up to 1 year
Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis
Baseline and up to 1 year
Participant outcomes after nivolumab treatment
Time Frame: Baseline and up to 1 year
Including disease stage, recurrence, disease progression, medical imaging test result, and death information
Baseline and up to 1 year
Participant medical history
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Participant cancer treatment history
Time Frame: Baseline
Baseline
Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation
Time Frame: Day 1
Day 1
Indication for nivolumab treatment
Time Frame: Day 1
Day 1
Nivolumab treatment duration
Time Frame: Up to 1 year
Up to 1 year
Time from surgery to nivolumab initiation
Time Frame: Day 1
Day 1
Nivolumab treatment regimen
Time Frame: Up to 1 year
Up to 1 year
Participant concomitant treatment(s)
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Participant systemic treatment(s)
Time Frame: Up to 1 year
Up to 1 year
Date of nivolumab treatment completion/discontinuation
Time Frame: Up to 1 year
Up to 1 year
Reasons for treatment discontinuation/cessation
Time Frame: Up to 1 year
Up to 1 year
Subsequent treatment after nivolumab discontinuation
Time Frame: Up to 1 year
Up to 1 year
Time to next treatment (TTNT)
Time Frame: Up to 1 year
Up to 1 year
Nivolumab treatment modifications in relation to the management of adverse events (AE)
Time Frame: Up to 1 year
Up to 1 year
Participant distant metastasis-free survival (DMFS)
Time Frame: Up to 1 year
Up to 1 year
Participant distant metastasis-free survival (DMFS) rates
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-1428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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