第二阶段试验,多中心,第一线帕克利塔塞尔-阿维卢马布治疗不可手术的血管肉瘤 (KCSG UN 18-15)
1Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
ESMO open
|January 22, 2026
概括
帕克利塔塞尔和阿维卢马布的第一线治疗显示出对不可切除的血管肉瘤,一种罕见的癌症有希望的疗效. 这种组合疗法在第二阶段研究中实现了50%的客观反应率,并具有可控的副作用.
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:
- 血管瘤是一种罕见的血管瘤,预后不佳.
- 由于瘤的位置或快速进展,手术切除通常是不可行的.
- 传统的化疗对抗血管肉瘤在很大程度上无效.
研究的目的:
- 评估帕克利塔塞尔加阿维卢马布作为不可切除血管肉瘤的第一线治疗方法的疗效和安全性.
- 确定客观反应率 (ORR),总生存率 (OS) 和无进展生存率 (PFS).
主要方法:
- 对32名无法切除局部晚期或转移性血管瘤患者进行的前性II期研究.
- 帕克利塔塞尔 (80 mg/m2) 在28天周期的第1,8,15天给予.
- 阿维卢马布 (10毫克/公斤) 每两周一次,直到疾病进展或无法接受的毒性.
主要成果:
- 客观反应率 (ORR) 为50.0% (16/32名患者),其中包括一个完整反应.
- 平均整体存活时间 (OS) 为14.5个月,平均无进展存活时间 (PFS) 为6.0个月.
- 90.9%的患者经历了不良事件 (AE),中性质衰竭和疼痛是最常见的;12.1%的患者有严重的AE.
结论:
- 艾维卢马布加上每周一次的帕克利塔塞尔在患有不可手术的血管肉瘤的患者中显示了初步的疗效和耐受性.
- 由于血管肉瘤的罕见性,需要进行更多的多中心,协作和翻译研究.
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