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

NCT06452329 — Completed, 260 participants, Bristol-Myers Squibb

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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

Registry	NCT06452329
Status	Completed
Study type	Observational
Enrollment	260 (Actual)
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Gastric Cancer, Gastroesophageal Junction Cancer
Interventions	Nivolumab (Drug)
Dates	start 2024-02-28, primary completion 2025-07-29, completion 2025-07-29, first posted 2024-06-11, last updated 2025-12-04
Locations	2 sites in China

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Participants who received first-line nivolumab therapy for advanced GC/GEJC		Drug: Nivolumab

Nivolumab (Drug): As prescribed by treating physician

+Outcome measures

Primary outcomes

Time to progression (TTP) [Up to 68 months]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Local Institution - 0001	Wuhan, Hubei	China
Tianjin Happy Life Technology Co., Ltd	Shanghai	China

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb