A Non-Interventional Study of Treatment Pattern and Clinical Outcomes in Chinese Participants With Gastric Cancer

Study Overview
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Brief Summary
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This prospective, multi-center, non-interventional study will evaluate the efficacy and safety of trastuzumab in routine clinical practice in Chinese participants with gastric or gastro-oesophageal cancer. The study will be conducted in 5 cohorts and eligible participants will be enrolled and assigned to the various cohorts according to human epidermal growth factor receptor 2 (HER2) status, disease stage and treatment with trastuzumab according to physician's decision. Treatment patterns and clinical outcomes in participants with gastric cancer in China will be evaluated. The total study duration is 60 months.

Official Title
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A Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria: Histologically confirmed cancer of the stomach or gastro-oesophageal junction or recurrent disease within 6 months before the date of recruitment Documented participant with trackable medical records HER2 status by immunohistochemistry (IHC) is known Specific Inclusion Criteria: Cohort I/II/IV: Participants with mGC: with recurrent or metastatic disease or with inoperable locally advanced disease Cohort III/V: Participants with operable non-mGC: TxNxM0 (according to American Joint Committee on Cancer [AJCC] edition 7th) Exclusion Criteria: Participants receiving regimen in a blinded trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort I: HER2-Positive mGC Treated With Trastuzumab<br>HER2-positive metastatic gastric cancer (mGC) participants who are treated with trastuzumab will be included in this cohort. As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with routine care practice and not dictated by the protocol. | Drug: Trastuzumab<br>* Trastuzumab administered in accordance with routine care practice.<br>* Other names: Herceptin;|
| Cohort II: HER2-Positive mGC not Treated With Trastuzumab<br>HER2-positive mGC participants who are not treated with trastuzumab will be included in this cohort. | |
| Cohort III: HER2-Positive non-mGC<br>HER2-positive non-mGC participants will be included in this cohort. | |
| Cohort IV: HER2-Negative mGC<br>HER2-negative mGC participants will be included in this cohort. | |
| Cohort V: HER2-Negative non-mGC<br>HER2-negative non-mGC participants will be included in this cohort. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Baseline up to death (up to approximately 5 years) | 
| Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) Criteria |  | Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) | 
| Cohort I, II, IV: Time to Treatment Failure (TTF), as Assessed by the Investigator Using RECIST V1.1 Criteria |  | Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) | 
| Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria |  | Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) | 
| Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria |  | Baseline up to disease recurrence or progression or death, whichever occurs first (up to approximately 5 years) | 
| Cohort III, V: Disease-Free Survival (DFS), as Assessed by the Investigator Using RECIST V1.1 Criteria |  | Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events |  | Baseline up to approximately 5 years | 
| Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments) |  | Baseline up to approximately 5 years | 
| Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline |  | Baseline up to first follow-up (up to approximately 5 years) | 
| Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons |  | Baseline up to first follow-up (up to approximately 5 years) |