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

NCT06585501 | Completed

• 1 other identifier: DS8201-0014-NIS-MA
• Study Type: observational
• Target: 805
• Locations: 1 country
• Sites: 9

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Keywords

Gastric Cancer; Gastroesophageal Junction Cancer; HER2; Real-world

Outcome Measures

Primary Outcomes (1)

• Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens

  72 months

Secondary Outcomes (6)

• 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

Study Arms (1)

GC/GEJC

Patients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC

Other: No drug

Interventions

No drug OTHER

This is a non-interventional study and no study drug will be provided.

GC/GEJC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC after October 1, 2017, and initiating first-line therapy between January 1, 2018, and March 31, 2023.

You may qualify if:

• 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).

You may not qualify if:

• Patients with other primary malignant tumors
• Patients enrolled in clinical trials and receiving active anti-cancer therapy after July.1, 2017 (excluding retrospective studies).

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (9)

Beijing Cancer Hospital

Beijing, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

Harbin Medical University Cancer Hospital

Harbin, China

Location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, China

Location

The First Hospital of China Medical University

Shenyang, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: August 15, 2024
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)