Prediction of Immunotherapy Efficacy Based on Transcriptome of CX3CR1+T Cell in Peripheral Blood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- objective response rate（ORR）
研究概览
简要总结
This study aimed to evaluate the correlation between the proportion of flow-sorted CX3CR1+T cells in peripheral blood and the CX3CR1+T-specific gene signature and the efficacy of immunotherapy.
详细描述
The status and abundance of T cells vary across tumor microenvironments (TMEs) may fundamentally influence response to immunotherapy in non-small cell lung cancer. CX3CR1+ CD8+ T cells showed high migration in and were enriched in the blood, whose amplification is strongly associated with response to anti-PD-1 therapy and better survival. However, the prediction performance of CX3CR1+ T features and characteristics has not been fully validated. This study intends to conduct a clinical trial based on CX3CR1+ CD8+T Cell in peripheral blood to verify the association of proportion and specific transcriptome signature of CX3CR1+T Cell in immunotherapy efficacy prediction. With the help of RECIST 1.1 criteria, the investigators evaluate the clinical response after prescribed cycles of treatment to explore the correlation between peripheral blood markers and immunotherapy efficacy. To develop a low cost, robust and accurate prototype prediction model for NSCLC patients who take anti-PD-1 drugs is investigators final translational purpose.
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
- •At least 18 years old;
- •Diagnosed as Non-small cell lung cancer by biopsy before treatment;
- •Prepare to receive PD(L)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs;
- •Lesion imaging can be measured and evaluated by RECIST1.1 standard;
- •Life expectancy exceeds 3 months;
- •ECOG score 0-2;
- •The newly IO treated patients did not receive immunotherapy, chemoradiotherapy before participate in the trial;
- •Sign informed consent and be willing to provide 5ml of peripheral blood for research
排除标准
- •Genetic test showed EGFR and ALK mutations;
- •Patients with other co-morbidities that may affect their follow-up and short-term survival;
- •Patients with any history of antitumor therapy;
- •Patients with a history of other systemic tumors;
- •The ineligible participants assessed by the researchers
结局指标
主要结局
objective response rate（ORR）
时间窗: 4 weeks
Imaging findings of CR, PR, and stable disease (SD) in all subjects evaluated according to RECIST V1.1 after completing 4 cycles of immunotherapy. best overall response (BoR) was evaluated in participants achieving complete and partial response.
次要结局
- progression-free survival (PFS)(1 year)
- overall survival (OS)(1 year)
研究者
Chang Chen
Chief Physician, Secretary of the Party Committee
Shanghai Pulmonary Hospital, Shanghai, China