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NCT Number: NCT06585501

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No drug

Other

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

Primary outcomes

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

    Time frame: 72 months

Secondary outcomes

  1. 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

  2. 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

  3. Real-world Progression-Free Survival

    Time frame: 72 months

  4. Real-world Time to Discontinuation

    Time frame: 72 months

  5. Real-world Time to Next Treatment 1

    Time frame: 78 months

  6. Overall Survival

    Time frame: 78 months

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

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

Acronym: REHEARSAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2024
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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