A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China

• Conditions: Gastric Cancer; Gastroesophageal Junction Cancer
• Interventions: Other: No drug

• Registration Number: NCT06585501
• Lead Sponsor: Daiichi Sankyo

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.

Study Timeline

• Study Start: 2024-08-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-05
• Last Update Posted: 2024-09-05
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GC/GEJC	No drug	Patients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC

Primary Outcome Measures

Name	Time	Method
Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens	72 months

Secondary Outcome Measures

Name	Time	Method
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
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
Real-world Time to Discontinuation	72 months
Real-world Time to Next Treatment 1	78 months
Overall Survival	78 months

Trial Locations

Locations (9)

Liaoning Cancer Hospital & Institute; 🇨🇳 Shenyang, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Affiliated Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, China

The First Hospital of China Medical University; 🇨🇳 Shenyang, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology; 🇨🇳 Wuhan, China