A Study to Evaluate Nivolumab in Patients With Unresectable Advanced/Metastatic Gastric Cancer and Gastroesophageal Junction Cancer

Active, not recruiting

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

• Registration Number: NCT06452329
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to collect and evaluate real-world data to enhance understanding of the effectiveness, and treatment patterns of first-line nivolumab treatment in patients with unresectable advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) in China

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-28
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-04-28
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Participants aged ≥ 18 years at date of first administration of nivolumab
• Confirmed diagnosis of unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) (histologically or cytologically)
• Participants newly received nivolumab as first-line (1L) treatment between 15 June 2018 and 30 June 2023
• Participants with at least one tumor assessment after index date except for death or discontinuation due to Adverse Events

Exclusion Criteria

• Participants with primary malignancies other than unresectable advanced or metastatic GC/GEJC
• Participants who participate in an interventional clinical trial in or before 1L nivolumab treatment for advanced/metastatic GC/GEJC
• Participants with known HER2 status positive
• Participants who investigator deems inappropriate for inclusion, for example clinical data was incomplete

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants who received first-line nivolumab therapy for advanced GC/GEJC	Nivolumab	-

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP)	Up to 68 months

Secondary Outcome Measures

Name	Time	Method
Participant baseline clinical characteristics	Baseline
Objective response rate (ORR)	Up to 68 months
Duration of response (DOR)	Up to 68 months
Participant socio-demographics	Baseline
Participant treatment patterns	Up to 68 months

Trial Locations

Locations (2)

Local Institution - 0001; 🇨🇳 Wuhan, Hubei, China

Tianjin Happy Life Technology Co., Ltd; 🇨🇳 Shanghai, China