Gastric Cancer
Conditions
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.
Interventions
DRUGTrastuzumab
Trastuzumab administered in accordance with routine care practice.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| Overall Survival | Baseline up to death (up to approximately 5 years) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Cohort I: Percentage of Participants With Non-Serious Adverse Events and Serious Adverse Events | Baseline up to approximately 5 years |
Countries
China
Outcome results
None listed