Clinical trial NCT06585501: A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China
Official title: Treatment and Testing Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China: A Retrospective Real-world Study (REHEARSAL)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastric Cancer
Gastroesophageal Junction Cancer
Keywords: Gastric Cancer
Gastroesophageal Junction Cancer
HER2
Real-world
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens
timeFrame: 72 months
Secondary outcomes:
measure: Percentage of HER2 sample type and testing method among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC
timeFrame: 72 months
measure: 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
timeFrame: 72 months
measure: Real-world Progression-Free Survival
timeFrame: 72 months
measure: Real-world Time to Discontinuation
timeFrame: 72 months
measure: Real-world Time to Next Treatment 1
timeFrame: 78 months
measure: Overall Survival
timeFrame: 78 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Study officials:
References: