Local Institution - 0001
Shanghai, 200030, China
Completed
NCT Number: NCT06499298
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Nivolumab
DrugAs per product label, as prescribed by treating physician
Primary outcomes
-
Participant disease-free survival (DFS)
Time frame: Up to 1 year
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
Negative (clear), positive (involved), close margins
-
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
Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis
-
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
-
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
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jul 12, 2024
- Registry last updated
- May 31, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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