PD-1抑制剂治疗的高危肺部毛玻璃样病变患者的活性和免疫动力学:来自单臂II期试验的见解

核心信息

  • 论文英文标题: The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial
  • 期刊: Signal Transduct Target Ther
  • 发表年份: 2024
  • DOI: 10.1038/s41392-024-01799-z
  • PMID/PMCID: 38637495; PMC11026465

研究概览

The primary endpoint was objective response rate (ORR). This is a single-arm, phase II trial (NCT04026841) using Simon's optimal two-stage design, of which 4 doses of sintilimab (200 mg per 3 weeks) were administrated in 36 enrolled multiple primary lung cancer (MPLC) patients with persistent high-risk (Lung-RADS category 4 or had progressed within 6 months) GGOs.

核心发现

Immune checkpoint inhibitors targeting the programmed cell death-1 (PD-1) protein significantly improve survival in patients with advanced non-small-cell lung cancer (NSCLC), but its impact on early-stage ground-glass opacity (GGO) lesions remains unclear.

This is a single-arm, phase II trial (NCT04026841) using Simon's optimal two-stage design, of which 4 doses of sintilimab (200 mg per 3 weeks) were administrated in 36 enrolled multiple primary lung cancer (MPLC) patients with persistent high-risk (Lung-RADS category 4 or had progressed within 6 months) GGOs.

The primary endpoint was objective response rate (ORR).

T/B/NK-cell subpopulations, TCR-seq, cytokines, exosomal RNA, and multiplexed immunohistochemistry (mIHC) were monitored and compared between responders and non-responders.

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血浆外泌体分离鉴定及长链RNA测序分析

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参考文献

原始论文: The activity and immune dynamics of PD-1 inhibition on high-risk pulmonary ground glass opacity lesions: insights from a single-arm, phase II trial Signal transduction and targeted therapy. 2024. DOI: 10.1038/s41392-024-01799-z. PMID/PMCID: 38637495; PMC11026465.