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

NCT06499298 | Completed FDA Drug

• 1 other identifier: CA209-1428
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastroesophageal Junction Cancer

Keywords

Esophageal Cancer (EC); Gastroesophageal Junction Cancer (GEJC)

Outcome Measures

Primary Outcomes (1)

• Participant disease-free survival (DFS)

  Up to 1 year

Secondary Outcomes (26)

• 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

Study Arms (1)

Participants receiving adjuvant nivolumab

Drug: Nivolumab

Interventions

Nivolumab DRUG

As per product label, as prescribed by treating physician

Participants receiving adjuvant nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Shanghai, 200030, China

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 12, 2024
• Study Start: December 3, 2024
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)