NCT06767436招募中不适用
A Multi-center Cohort Study to Evaluate the Real-world Efficacy and Safety of Trastuzumab-deruxtecan in Advanced Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
- Institutions will be selected
- This study aims to collect real-world data, targeting patients who started treatment with Enhertu from September 2022, for clinical data collection
- Among patients treated with Enhertu, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024
- For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration)
- Efficacy evaluation
详细描述
- Institutions will be selected through the Gastric Cancer Subcommittee of the Korean Cancer Study Group.
- This study aims to collect real-world data, targeting patients who started treatment with trastuzumab-deruxtecan from September 2022, for clinical data collection.
- Among patients treated with trastuzumab-deruxtecan, those who have passed away or are no longer visiting due to hospice care will have their clinical data collected without consent until August 19, 2024.
- For patients who are scheduled to receive Enhertu treatment, are currently undergoing treatment, or have previously undergone treatment but experienced disease progression and are now receiving subsequent chemotherapy (i.e., patients with newly added data after registration), data will be collected with consent until March 31, 2027.
- Efficacy evaluation will include overall survival (OS), progression-free survival (PFS), and tumor response rate (TRR)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years or older.
- •Patients with pathologically confirmed metastatic, recurrent, or unresectable gastric/gastroesophageal adenocarcinoma.
- •Patients whose tumor tissue shows HER2 immunohistochemistry (IHC) results of 3+ or 2+ with in-situ hybridization (ISH) positivity.
- •Patients who received Trastuzumab Deruxtecan as third-line or later treatment.
排除标准
- •Patients with HER2-negative gastric cancer.
- •Patients who did not provide consent to participate in the study.
- •Patients who received Trastuzumab Deruxtecan as first-line or second-line treatment as part of a clinical trial.
结局指标
主要结局
Progression-free Survival
时间窗: 1 year
To present real-world clinical outcomes of trastuzumab-deruxtecan as third-line or later treatment in HER2-positive gastric cancer.
次要结局
- Number of participants with treatment-related adverse events(1 year)
- analyze the correlation(1 year)
研究者
Minkyu Jung
Principal Investigator
Yonsei University
研究点 (1)
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