A Prospective Study of Constructing Immune Repertoire Using Next-generation Sequencing (NGS) to Monitor the Therapeutic Effect in NSCLC Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- T cell repertoire
研究概览
简要总结
This study is designed to evaluate the untreated NSCLC patients. After participants have accepted chemotherapy, radiotherapy, and immunotherapy, the investigators used the next generation sequence technology (NGS) to construct immune repertoire to detective variation of patients' immune state and to monitor patients' therapeutic effect. The investigators are aim to explore the novel clone sequence as potential therapy target.
详细描述
Lung cancer was one of the most deadly tumors in the world. The standard of care for patients is platinum-based doublet chemotherapy concurrent with radiotherapy. As for patients with a mutant epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase(ALK), EGFR or ALK tyrosine kinase inhibitors (TKIs) are the standard first-line therapy. Now, the Food and Drug Administration approved Ipilimumab, Nivolumab, and Pembrolizumab as first-line or second-line therapy for NSCLC. However, there was no reports about therapeutic effect for NSCLC patients through detecting herself immune state, immune repertoire could explore patients' immune clonality and diversity using NGS technology.The investigators look forward to illuminate the mechanism of patients antitumor action.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 是
入选标准
- •Pathologically verified stage IV non-small cell lung cancer without treated.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Major organs function normally
- •Women at pregnant ages should be under contraception
- •Willing and able to provide informed consent
排除标准
- •Pathology is mixed type•
- •Poor vasculature
- •Coagulopathy, or ongoing thrombolytics and/or anticoagulation
- •Blood-borne infectious disease, e.g. hepatitis B
- •History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
- •Other conditions requiring exclusion deemed by physician
研究组 & 干预措施
Immunotherapy,chemotherapy,radiotherapy
Pembrolizumab will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent.The peripheral blood will be collected at 3 weeks,2 months, 6 months,an average of 1 year
干预措施: pembrolizumab (Drug)
结局指标
主要结局
T cell repertoire
时间窗: baseline, 2 months, 6 months, 1 year
peripheral blood was collected at baseline,3 weeks,2 months, 6 months,an average of 1 year
次要结局
- peripheral blood circulating tumor DNA(baseline, 2 months, 6 months, 1 year)
研究者
You Lu
Chair of Department of Thoracic Oncology
Sichuan University