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一个扩展释放siRNA植入物的第二阶段试验,针对局部晚期胰腺癌中的KRAS G12D/V

Brinda Alagesan¹, Anna M Varghese², Celina Ang³

¹Memorial Sloan Kettering Cancer Center New York, New York United States.

Clinical cancer research : an official journal of the American Association for Cancer Research

|January 13, 2026

概括

这项研究研究了一种新的siRNA (siG12D-LODER) 与局部晚期胰腺癌 (LAPC) 的化疗相结合. 治疗显示出安全性和耐受性,特别是在KRAS G12D/V突变患者中.

科学领域:

在瘤学瘤学.
分子生物学分子生物学
遗传学遗传学是一个

背景情况:

局部晚期胰腺癌 (LAPC) 占胰腺癌诊断的很大一部分.
KRAS突变,特别是G12D/V,是胰腺癌的常见驱动因素,带来治疗挑战.

研究的目的:

为了评估siG12D-LODER的疗效和安全性,一个延长释放siRNA向KRAS G12D/V突变,与LAPC的化疗结合使用.
评估总生存率 (OS) 和客观反应率 (ORR) 作为第二阶段研究中的主要终点.

主要方法:

一个双队列,第2期多中心,开放标签研究 (NCT01676259) 招募了59名LAPC患者.
第1队列:siG12D-LODER加上凝胺/纳布-帕克利塔塞尔与单独化疗的随机比较.
队列2:单臂评估siG12D-LODER加标准化疗 (修改的FOLFIRINOX或凝胺/纳布-帕克利塔塞尔).

主要成果:

在第1队列中,在未经选择的mITT群体中,双臂间的中位数OS相似 (22.7 vs 21.9个月).
在第1队列的KRAS G12D/V小组中,OS为siG12D-LODER加化学疗法22.7个月,仅用化学疗法为13.4个月.
队列2在mITT群体中显示ORR为31.6%,在KRAS G12D/V小组中为57.1%.

结论:

siG12D-LODER与化疗结合使用是安全的,并且在LAPC患者中耐受良好.
组合疗法需要进一步研究,特别是对于携带KRAS G12D/V突变的LAPC患者.

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