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

August 20, 2025 updated by: Daiichi Sankyo

Treatment and Testing Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China: A Retrospective Real-world Study (REHEARSAL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

805

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Cancer Hospital
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Hangzhou, China
        • Zhejiang Provincial People's Hospital
      • Harbin, China
        • Harbin medical university cancer hospital
      • Jinan, China
        • Affiliated Cancer Hospital of Shandong First Medical University
      • Shenyang, China
        • The First Hospital of China Medical University
      • Shenyang, China
        • Liaoning Cancer Hospital & Institute
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Wuhan, China
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GC/GEJC
Patients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC
Other: No drug
This is a non-interventional study and no study drug will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens
Time Frame: 72 months
72 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of HER2 sample type and testing method among patients with a first diagnosis of locally advanced or metastatic HER2-positive GC/GEJC
Time Frame: 72 months
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
Time Frame: 72 months
72 months
Real-world Progression-Free Survival
Time Frame: 72 months
72 months
Real-world Time to Discontinuation
Time Frame: 72 months
72 months
Real-world Time to Next Treatment 1
Time Frame: 78 months
78 months
Overall Survival
Time Frame: 78 months
78 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

July 30, 2025

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS8201-0014-NIS-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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