Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline in molecular biomarkers at time on best overall response
研究概览
简要总结
To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.
详细描述
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.
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
- •Male/female patients aged over 18 years.
- •Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
- •HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive, HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
- •At least one measurable lesion should be confirmed by imaging examination.
- •Eligible peripheral blood samples
- •Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.
- •For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.
- •For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.
- •Willing to provide clinicopathological information and imaging information.
排除标准
- •Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
- •With second primary malignant diseases.
- •Other situations assessed by investigator can disturb quality control of the investigation.
结局指标
主要结局
Change from baseline in molecular biomarkers at time on best overall response
时间窗: 36 months
Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file.
次要结局
- Change from baseline in molecular biomarkers at time on disease progression(36 months)
研究者
Jun Zhang
Chair of Department of Oncology
Ruijin Hospital