苏鲁法提尼布加帕克利塔塞尔作为晚期胃癌的二线治疗:单臂,第二阶段临床试验
Ting Han1, Meng Zhuo1, Xinyi Zheng2
1Department of Oncology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.
Cellular oncology (Dordrecht, Netherlands)
|November 3, 2025
概括
苏鲁法替尼与帕克利塔克塞尔结合,在晚期胃癌患者中显示出有前途的结果. 这种组合疗法提供了更好的疗效和可管理的安全性,特别是对于那些以前接受过免疫治疗的人来说.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 临床试验 临床试验
背景情况:
- 晚期胃癌的二线治疗通常涉及组合疗法.
- 与化疗相结合的抗血管原剂已经显示出更好的疗效.
- 苏鲁法提尼布是一种多酶抑制剂,具有抗血管原和免疫调节的特性.
研究的目的:
- 评估surufatinib加paclitaxel作为晚期胃癌的二线治疗方法的疗效和安全性.
- 评估客观反应率 (ORR),疾病控制率 (DCR),无进展生存率 (PFS) 和整体生存率 (OS).
主要方法:
- 进行了一项单臂2期临床试验.
- 患者 (18-75岁) 患有HER2-阴性不可切除或转移性胃/胃食道结腺癌,但第一线治疗失败的患者被纳入.
- 治疗包括苏拉法提尼布 (每天250毫克) 加帕克利塔塞尔 (150毫克/米2每3周),长达6个周期,然后是维持苏拉法提尼布.
主要成果:
- 在32名可评估患者中,ORR为25.0%,DCR为87.5%.
- 中位数PFS为5.7个月,中位数OS为10.8个月.
- 在先前接受免疫治疗的患者中 (n=26),中位数的生存期为14.4个月. 与治疗相关的≥3级不良事件发生在54.3%的患者中.
结论:
- 在晚期胃癌的二线治疗中,surufatinib加paclitaxel显示出有希望的疗效和可控的安全性.
- 组合疗法在以前免疫疗法失败的患者中显示出特别的益处.
- 对这种结合用于胃癌治疗的进一步研究是有必要的.
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