Prospectively Predict the Efficacy of Precise Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Levels of circulating exosomal lncRNA-GC1
研究概览
简要总结
To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC
详细描述
The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific tumor burden marker and this novel biomarker showed promising efficiency in monitoring disease progression during treatment.
Hence in this stuty, the investigator plan to recruit a prospective cohort to support the conclusions, and provide biomarkers 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 80 Years（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
Levels of circulating exosomal lncRNA-GC1
时间窗: Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year
Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.
次要结局
- Survival outcomes of circulating exosomal lncRNA-GC1(up to 3 years)
研究者
Lin Chen
Director of Department of General Surgery, Chinese PLA General Hospital
Chinese PLA General Hospital