A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi-omics Liquid Biopsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- EV-Score
研究概览
简要总结
To vertify the function of EV-score on predicting & monitoring immunotherapeutic outcomes of GC
详细描述
Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment.
Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.
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
- •Having signed informed consent
- •Age≥ 18 years old
- •Histologically confirmed gastric adenocarcinoma
- •Unresectable recurrent or metastatic disease
- •Measurable disease according to the RECIST criteria
- •Life expectancy of ≥3 month
- •No prior chemotherapy of the study more than 4 weeks
- •Immunotherapy regimens were included in the treatment
排除标准
- •Other previous malignancy within 5 year
- •Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
- •Pregnancy or lactation period
- •Legal incapacity
结局指标
主要结局
EV-Score
时间窗: EV-Score was detected, analysis and reported at the baseline of the treatment.
EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV
次要结局
- Survival significance of EV-Score(up to 3 years)
研究者
Shen Lin
Director of GI oncology Affiliation: Peking University
Peking University