在耐火固体瘤中,对脂质体里诺基坦 (ONIVYDE®) 与TAS-102 (LONSURF®) 结合的I期研究
Nai-Jung Chiang1,2,3, Li-Yuan Bai4, I-Wei Ho1,2
1Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Investigational new drugs
|June 4, 2025
概括
这项研究确定了在晚期癌症中将Onivyde (脂质体内氨基酸) 与TAS-102结合使用的安全剂量. 在耐火固体瘤患者中,推剂量显示出有前途的安全性和疗效.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 癌症治疗方法 癌症治疗方法
背景情况:
- 欧尼维德 (脂质体内氨基酸) 已被批准用于晚期胰腺癌.
- TAS-102 (trifluridine/tipiracil) 适用于转移性结肠直肠癌和胃癌.
- 该组合的安全性和最佳剂量需要对耐火固体瘤进行调查.
研究的目的:
- 确定脂质体里诺他干加TAS-102.2.的最大耐受剂量 (MTD).
- 确定该组合治疗的推第二阶段剂量 (RP2D).
- 评估组合治疗方案的安全性和耐受性.
主要方法:
- 采用了一个多中心,I期,3+3剂量升级研究设计.
- 患有治疗不耐药的固体恶性瘤的患者接受了脂质体里诺他干和TAS-102.2的升级剂量.
- 排除标准包括特定的UGT1A1遗传变异;允许预防性G-CSF.
主要成果:
- 该MTD被确定为脂质体内氨基酸70 mg/m2和TAS-102 30 mg/m2 (水平4A).
- RP2D被确定为70/30 mg/m2,扩展队列证实了安全性.
- 3-4级与治疗相关的不良事件发生在44.2%的患者中,主要是中性质减退和腹.
结论:
- 在RP2D中结合脂质体内氨基酸和TAS-102,在耐火固体瘤中显示出可接受的安全性.
- 观察到有前途的初步疗效,特别是在神经内分泌瘤,胃癌和食道癌中.
- 在II期试验中对这种组合疗法进行进一步的研究是有必要的.
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