Using Single-cell Sequencing to Explore Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Single-cell profiling
研究概览
简要总结
The goal of this study is to analyze the tumor microenvironment (TME) in gastric cancer patients treated with combined immunotherapy and chemotherapy. The main questions it aims to answer are:
- Provide profiles of TME between pre-treatment and post-treatment to gain insights into the mechanisms of immunotherapy combined with chemotherapy in advanced gastric cancer
- Investigate the crucial factors affecting treatment efficacy by comparing gastric cancer patients with varying treatment responses
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-bedridden, aged 18 to 70 years old;
- •Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
- •Histologically confirmed gastric adenocarcinoma with evaluable lesions based on RECIST 1.1;
- •Advanced gastric cancer;
- •Ready for receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab
排除标准
- •History of other malignant diseases in the last 5 years;
- •Prior chemotherapy, radiotherapy or immunotherapy;
- •Not receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab.
研究组 & 干预措施
Response
Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy
干预措施: Gastroscopic biopsy (Procedure)
Pre-treatment
Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy
干预措施: SOX plus PD-1 inhibitor (Drug)
Pre-treatment
Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy
干预措施: Gastroscopic biopsy (Procedure)
Post-treatment
Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy
干预措施: SOX plus PD-1 inhibitor (Drug)
Post-treatment
Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy
干预措施: Gastroscopic biopsy (Procedure)
Response
Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy
干预措施: SOX plus PD-1 inhibitor (Drug)
Non-response
Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy
干预措施: SOX plus PD-1 inhibitor (Drug)
Non-response
Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy
干预措施: Gastroscopic biopsy (Procedure)
结局指标
主要结局
Single-cell profiling
时间窗: 6 months
Single-cell transcriptome and immune repertoire sequencing
次要结局
未报告次要终点
研究者
Xinxin Wang
Prof.
Chinese PLA General Hospital