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

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

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 Overview

• Status: Completed
• Conditions: Esophageal Cancer; Gastroesophageal Junction Cancer
• Intervention / Treatment: Drug: Nivolumab

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200030
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult participants from China with Stage II/III Esophageal Cancer/Gastroesophageal Junction Cancer (EC/GEJC) who initiated nivolumab treatment in routine clinical practice between June 27, 2022 and October 31, 2023.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants receiving adjuvant nivolumab	Drug: Nivolumab; As per product label, as prescribed by treating physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participant disease-free survival (DFS)	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Negative (clear), positive (involved), close margins	Baseline
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)	Including PD-L1 expression, HER2 status, Epstein-Barr virus positivity, tumor metastasis	Baseline and up to 1 year
Participant outcomes after nivolumab treatment	Including disease stage, recurrence, disease progression, medical imaging test result, and death information	Baseline and up to 1 year
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Actual): April 16, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal Cancer (EC); Gastroesophageal Junction Cancer (GEJC)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Nivolumab
• Other Study ID Numbers: CA209-1428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes