Gastric Cancer, Gastroesophageal Junction Cancer
Conditions
Keywords
Gastric Cancer, Gastroesophageal Junction Cancer, HER2, Real-world
Brief summary
This study will be conducted to retrospectively evaluate the treatment patterns in first-line, second-line, and subsequent lines of therapy for HER2-positive Gastric Cancer/Gastroesophageal Junction Cancer (GC/GEJC) patients.
Detailed description
This is a multicenter, non-interventional, retrospective real-world study to analyze the treatment patterns for patients with GC/GEJC in the first-line, second-line, and subsequent lines of treatment. The study will also assess different HER2 sample types, testing methods, and HER2 re-biopsy situations. By evaluating the treatment and testing patterns in clinical practice, this study aims to provide evidence and recommendations for improving the strategies for the treatment and testing of HER2-positive GC/GEJC patients.
Interventions
OTHERNo drug
This is a non-interventional study and no study drug will be provided.
Sponsors
Daiichi Sankyo
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pathologically diagnosed locally advanced unresectable or metastatic GC/GEJC (limited to those diagnosed since October 1, 2017) and initiating first-line treatment between January 1, 2018, and March 31, 2023 * Patients aged ≥ 18 years at the time of diagnosis with locally advanced unresectable or metastatic GC/GEJC; HER2-positive status2, determined by either tissue samples from the first biopsy or liquid biopsy samples (if a patient has both tissue and liquid biopsy samples, tissue samples will be the standard).
Exclusion criteria
* Patients with other primary malignant tumors * Patients enrolled in clinical trials and receiving active anti-cancer therapy after July.1, 2017 (excluding retrospective studies). * Patients with critical missing data in medical records or otherwise deemed for inclusion by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens | 72 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of re-biopsies and re-biopsies with HER2-positive results among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC | 72 months |
| Real-world Progression-Free Survival | 72 months |
| Percentage of HER2 sample type and testing method among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC | 72 months |
| Real-world Time to Next Treatment 1 | 78 months |
| Overall Survival | 78 months |
| Real-world Time to Discontinuation | 72 months |
Countries
China
Outcome results
None listed