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

NCT06499298 — Completed, 64 participants, Bristol-Myers Squibb

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Retrospective Evaluation of Nivolumab in Adjuvant Esophageal Cancer/Gastroesophageal Junction Cancer: A Non-interventional Study in China

RegistryNCT06499298
StatusCompleted
Study typeObservational
Enrollment64 (Actual)
SponsorBristol-Myers Squibb (Industry)
ConditionsEsophageal Cancer, Gastroesophageal Junction Cancer
InterventionsNivolumab (Drug)
Datesstart 2024-12-03, primary completion 2025-04-16, completion 2025-04-16, first posted 2024-07-12, last updated 2025-05-31
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Participants receiving adjuvant nivolumabDrug: Nivolumab
  • Nivolumab (Drug): As per product label, as prescribed by treating physician

+Outcome measures

Primary outcomes

  • Participant disease-free survival (DFS) [Up to 1 year]

Secondary outcomes

  • Participant socio-demographics [Baseline and up to 1 year]
  • Date of tumor initial diagnosis [Baseline]
  • Tumor location at initial diagnosis [Baseline]
  • Tumor histology at initial diagnosis [Baseline]
  • Resected tumor margins status [Baseline]: Negative (clear), positive (involved), close margins
  • Eastern Cooperative Oncology Group (ECOG) performance status [Baseline and up to 1 year]
  • Pathological lymph-node status [Baseline and up to 1 year]
  • Pathological tumor status [Baseline and up to 1 year]
  • Participant biomarkers (if available) [Baseline and up to 1 year]: Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis
  • Participant outcomes after nivolumab treatment [Baseline and up to 1 year]: Including disease stage, recurrence, disease progression, medical imaging test result, and death information
  • Participant medical history [Baseline and up to 1 year]
  • Participant cancer treatment history [Baseline]
  • Esophageal Cancer (EC) or gastroesophageal junction cancer (GEJC) stage at nivolumab treatment initiation [Day 1]
  • Indication for nivolumab treatment [Day 1]
  • Nivolumab treatment duration [Up to 1 year]
  • Time from surgery to nivolumab initiation [Day 1]
  • Nivolumab treatment regimen [Up to 1 year]
  • Participant concomitant treatment(s) [Baseline and up to 1 year]
  • Participant systemic treatment(s) [Up to 1 year]
  • Date of nivolumab treatment completion/discontinuation [Up to 1 year]
  • Reasons for treatment discontinuation/cessation [Up to 1 year]
  • Subsequent treatment after nivolumab discontinuation [Up to 1 year]
  • Time to next treatment (TTNT) [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) [Up to 1 year]
  • Participant distant metastasis-free survival (DMFS) rates [Up to 1 year]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Local Institution - 0001ShanghaiChina

+Investigators

  • Bristol-Myers Squibb, Study director, Bristol-Myers Squibb