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OpenTrials
Completed

NCT Number: NCT06452329

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

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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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Drug

As prescribed by treating physician

Primary outcomes

  1. Time to progression (TTP)

    Time frame: Up to 68 months

Secondary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 68 months

  2. Duration of response (DOR)

    Time frame: Up to 68 months

  3. Participant socio-demographics

    Time frame: Baseline

  4. Participant baseline clinical characteristics

    Time frame: Baseline

  5. Participant treatment patterns

    Time frame: Up to 68 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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