Gastric CancerREHEARSALNCT06585501
A Study of Treatment Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China
An observational study of Gastric Cancer and Gastroesophageal Junction Cancer, run by Daiichi Sankyo at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- No drug
- How many people
- 805 participants
- Where
- 9 sitesChina
- Study dates
- 15 Aug 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Cancer Hospital
Beijing
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Zhejiang Provincial People's Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Liaoning Cancer Hospital & Institute
Shenyang
The First Hospital of China Medical University
Shenyang
The First Affiliated Hospital of Soochow University
Suzhou
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Being tested
- No drug
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2, Real-world
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No drugOther
This is a non-interventional study and no study drug will be provided.
| Study group | Role | What they receive |
|---|---|---|
| GC/GEJC | Patients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens
Measured: 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
Measured: 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
Measured: 72 months
Real-world Progression-Free Survival
Measured: 72 months
Real-world Time to Discontinuation
Measured: 72 months
Real-world Time to Next Treatment 1
Measured: 78 months
Overall Survival
Measured: 78 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start15 Aug 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585501
- Sponsor's protocol ID
- DS8201-0014-NIS-MA
- Acronym
- REHEARSAL
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42217113
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Testing Patterns in HER2-positive Unresectable and Advanced Gastric/ Gastroesophageal Junction Cancer in China: A Retrospective Real-world Study (REHEARSAL)
- ClinicalTrials.gov ID
- NCT06585501
- Acronym / sponsor ID
- REHEARSAL / DS8201-0014-NIS-MA
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2, Real-world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC/GEJC | – | Other: No drugPatients diagnosed with locally advanced unresectable or metastatic HER2-positive GC/GEJC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No drugThis is a non-interventional study and no study drug will be provided. | Other | GC/GEJC |
Primary outcome
Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens
Time frame: 72 months
6 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
Time frame: 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
Real-world Progression-Free Survival
Time frame: 72 months
Real-world Time to Discontinuation
Time frame: 72 months
Real-world Time to Next Treatment 1
Time frame: 78 months
Overall Survival
Time frame: 78 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Derived from this study: PubMed 42217113Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Gastroesophageal Junction Cancer, run by Daiichi Sankyo at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients receiving first-line, second-line, and third-line anti-tumor regimens (time frame: 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.