A Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)
Overview
- Phase
- Not Applicable
- Intervention
- Trastuzumab
- Conditions
- Gastric Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 1600
- Locations
- 81
- Primary Endpoint
- Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort I: HER2-Positive mGC Treated With Trastuzumab
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.
Intervention: Trastuzumab
Outcomes
Primary Outcomes
Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Overall Survival
Time Frame: Baseline up to death (up to approximately 5 years)
Cohort III, V: Event-Free Survival (EFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
Time Frame: Baseline up to disease recurrence or progression or death, whichever occurs first (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
Time Frame: 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
Time Frame: Baseline up to disease 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
Time Frame: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Secondary Outcomes
- 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 Participants Who Decline to the Recommendation Categorized by Reasons(Baseline up to first follow-up (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))