NCT06452329
Completed
Not Applicable
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
Bristol-Myers Squibb2 sites in 1 country260 target enrollmentStarted: February 28, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 260
- Locations
- 2
- Primary Endpoint
- Time to progression (TTP)
Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Participants who received first-line nivolumab therapy for advanced GC/GEJC
Intervention: Nivolumab (Drug)
Outcomes
Primary Outcomes
Time to progression (TTP)
Time Frame: Up to 68 months
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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