The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.
The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.
详细描述
In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
- •Eastern Cooperative Oncology Group performance status of 0 to 1
- •Male or female; ≥ 19 years of age
- •On or progression after 1st line palliative chemotherapy
- •Subjects with evaluable lesion (using RECIST 1.1 criteria)
- •Subjects who meet the following criteria:
- •Absolute neutrophil count ≥ 1000 /µL
- •Platelet count ≥ 75,000/ µL
- •Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min
- •aspartate aminotransferase and alanine transaminase 3 x upper limit of normal
排除标准
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
研究组 & 干预措施
biomarker group
400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets [Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel.
干预措施: biomarker screening (Other)
control group
Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio.
干预措施: biomarker screening (Other)
结局指标
主要结局
progression free survival
时间窗: 6 weeks
progression free survival
次要结局
未报告次要终点