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

Bristol-Myers Squibb64 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Esophageal Cancer Gastroesophageal Junction Cancer

Interventions

NivolumabDRUG

As per product label, as prescribed by treating physician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Local Institution - 0001

Shanghai, China

Outcomes

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

Negative (clear), positive (involved), close margins

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)

Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis

Time frame: Baseline and up to 1 year

Participant outcomes after nivolumab treatment

Including disease stage, recurrence, disease progression, medical imaging test result, and death information

Data from ClinicalTrials.gov

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