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

Retrospective Evaluation of Nivolumab in First-Line Unresectable Advanced or Metastatic Gastric Cancer (GC) and Gastroesophageal Junction Cancer (GEJC): A Non-interventional Observational Study in China

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06452329
Enrollment
260
Registered
2024-06-11
Start date
2024-02-28
Completion date
2025-07-29
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

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

Interventions

DRUGNivolumab

As prescribed by treating physician

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to progression (TTP)Up to 68 months

Secondary

MeasureTime frame
Objective response rate (ORR)Up to 68 months
Duration of response (DOR)Up to 68 months
Participant socio-demographicsBaseline
Participant baseline clinical characteristicsBaseline
Participant treatment patternsUp to 68 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026