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

Hoffmann-La Roche1,600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,600

Conditions

Gastric Cancer

Interventions

TrastuzumabDRUG

Trastuzumab administered in accordance with routine care practice.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (81)

Anyang Tumor Hosptial

Anyang, China

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, China

Peking University First Hospital

Beijing, China

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

Beijing, China

Peking University Third Hospital

Beijing, China

Outcomes

Primary Outcomes

Overall Survival

Time frame: 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

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 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)

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)

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

Time frame: Baseline up to approximately 5 years

Percentage of Participants Treated with Various Initial and Subsequent Therapies (Chemotherapy, Targeted, or Investigational Treatments)

Time frame: Baseline up to approximately 5 years

Cohort II: Percentage of Healthcare Professionals (HCPs) Who Recommend Treatment According to Guideline

Time frame: Baseline up to first follow-up (up to approximately 5 years)

Cohort II: Percentage of Participants Who Decline to the Recommendation Categorized by Reasons

Time frame: Baseline up to first follow-up (up to approximately 5 years)