A Non-Interventional, Registry Study for Chinese Gastric Cancer Patients With HER2 Status: Clinical and Pathological Characteristics, Treatment Patterns and Clinical Outcomes (EVIDENCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,600
- 试验地点
- 81
- 主要终点
- Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Participants receiving regimen in a blinded trial
研究组 & 干预措施
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.
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Cohort I, II, IV: Progression-Free Survival (PFS), as Assessed by the Investigator Using RECIST V1.1 Criteria
时间窗: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
Overall Survival
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline up to disease progression or death, whichever occurs first (up to approximately 5 years)
次要结局
- 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))