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

Active, not recruiting

• Conditions: Esophageal Cancer; Gastroesophageal Junction Cancer
• Interventions: Drug: Nivolumab

• Registration Number: NCT06499298
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-12
• Study Start: 2024-12-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-05-23
• Study Completion: 2025-06-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving adjuvant nivolumab	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Participant disease-free survival (DFS)	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
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
Eastern Cooperative Oncology Group (ECOG) performance status	Baseline and up to 1 year
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
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
Resected tumor margins status	Baseline	Negative (clear), positive (involved), close margins
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 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
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)	Up to 1 year
Participant socio-demographics	Baseline and up to 1 year
Participant distant metastasis-free survival (DMFS) rates	Up to 1 year

Trial Locations

Locations (1)

Local Institution - 0001; 🇨🇳 Shanghai, China