NCT06499298
Completed
Not Applicable
Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Participant disease-free survival (DFS)
Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Participants receiving adjuvant nivolumab
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
Participant disease-free survival (DFS)
Time Frame: Up to 1 year
Secondary Outcomes
- Date of tumor initial diagnosis(Baseline)
- Date of nivolumab treatment completion/discontinuation(Up to 1 year)
- Time to next treatment (TTNT)(Up to 1 year)
- Nivolumab treatment regimen(Up to 1 year)
- Eastern Cooperative Oncology Group (ECOG) performance status(Baseline and up to 1 year)
- Participant outcomes after nivolumab treatment(Baseline and up to 1 year)
- Participant medical history(Baseline and up to 1 year)
- Indication for nivolumab treatment(Day 1)
- Nivolumab treatment duration(Up to 1 year)
- Time from surgery to nivolumab initiation(Day 1)
- Participant socio-demographics(Baseline and up to 1 year)
- Resected tumor margins status(Baseline)
- Participant cancer treatment history(Baseline)
- Participant concomitant treatment(s)(Baseline and up to 1 year)
- Participant systemic treatment(s)(Up to 1 year)
- Subsequent treatment after nivolumab discontinuation(Up to 1 year)
- Tumor location at initial diagnosis(Baseline)
- Tumor histology at initial diagnosis(Baseline)
- Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation(Day 1)
- Pathological tumor status(Baseline and up to 1 year)
- Pathological lymph-node status(Baseline and up to 1 year)
- Participant biomarkers (if available)(Baseline and up to 1 year)
- Reasons for treatment discontinuation/cessation(Up to 1 year)
- Nivolumab treatment modifications in relation to the management of adverse events (AE)(Up to 1 year)
- Participant distant metastasis-free survival (DMFS) rates(Up to 1 year)
- Participant distant metastasis-free survival (DMFS)(Up to 1 year)
Investigators
Study Sites (1)
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