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NCT06452329 Clinical Trial

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

Gastric Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06452329
Other study ID # CA209-1429
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 28, 2024
Est. completion date July 31, 2025

Study information
Verified date June 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 260
Est. completion date July 31, 2025
Est. primary completion date April 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nivolumab
As prescribed by treating physician

Locations
Country Name City State
China Tianjin Happy Life Technology Co., Ltd Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to progression (TTP) Up to 68 months
Secondary Objective response rate (ORR) Up to 68 months
Secondary Duration of response (DOR) Up to 68 months
Secondary Participant socio-demographics Baseline
Secondary Participant baseline clinical characteristics Baseline
Secondary Participant treatment patterns Up to 68 months
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Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
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Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
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