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

NCT06585501 — Completed, 805 participants, Daiichi Sankyo

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

RegistryNCT06585501, acronym REHEARSAL
StatusCompleted
Study typeObservational
Enrollment805 (Actual)
SponsorDaiichi Sankyo (Industry)
ConditionsGastric Cancer, Gastroesophageal Junction Cancer
InterventionsNo drug (Other)
Datesstart 2024-08-15, primary completion 2025-07-30, completion 2025-07-30, first posted 2024-09-05, last updated 2025-08-21
Locations9 sites in China

Related Papers Related Patents Related Grants Related Experts
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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
GC/GEJCOther: No drugPatients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC
  • No drug (Other): This is a non-interventional study and no study drug will be provided.

+Outcome measures

Primary outcomes

  • Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens [72 months]

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (9)

FacilityCityCountryStatus
Beijing Cancer HospitalBeijingChina
The First Affiliated Hospital of Fujian Medical UniversityFuzhouChina
Zhejiang Provincial People's HospitalHangzhouChina
Harbin Medical University Cancer HospitalHarbinChina
Affiliated Cancer Hospital of Shandong First Medical UniversityJinanChina
Liaoning Cancer Hospital & InstituteShenyangChina
The First Hospital of China Medical UniversityShenyangChina
The First Affiliated Hospital of Soochow UniversitySuzhouChina
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyWuhanChina

+Publications

  • Results publication: Wang Y, Liu B, Zhang J, Zhang Y, Yuan X, Chen K, Xie X, Qu X, Yang L, Zhang L, Zhang X. Real-World Treatment Patterns, HER2 Testing Practices, and Clinical Outcomes in HER2-Positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. Adv Ther. 2026 Aug;43(8):3633-3648. doi: 10.1007/s12325-026-03613-4. Epub 2026 May 30. PMID 42217113