辛提利马布加上阿克西提尼布治疗高级酸盐酸酶缺乏细胞癌:第二阶段非随机临床试验
Xingming Zhang1, Haoyang Liu1, Jiayu Liang1
1Department of Urology, Institute of Urology, Sichuan Clinical Research Center for Kidney and Urologic Diseases, West China Hospital, Sichuan University, Chengdu, China.
JAMA oncology
|August 14, 2025
概括
辛提利马布加上阿克西蒂尼布在晚期烟酸酸酶缺陷细胞癌 (FH缺陷RCC) 患者中显示出56%的客观应答率和19.8个月的无进展生存期. 这种组合疗法为这种致命的癌提供了一个有希望的,可管理的治疗选择.
科学领域:
- 在瘤学瘤学.
- 腎臟病學 (nephrology) 是一種醫學.
- 免疫治疗是一种免疫疗法.
背景情况:
- 酸酸酶缺陷细胞癌 (FH缺陷RCC) 是一种具有有限治疗选择的侵袭性癌.
- 迫切需要新的治疗策略,以改善晚期FH缺乏RCC患者的治疗结果.
研究的目的:
- 评估结合辛蒂利马布 (一种免疫检查点抑制剂) 与阿克西替尼 (一种氨酸激酶抑制剂) 对晚期FH缺乏RCC的疗效和安全性.
- 评估客观应答率 (ORR) 和无进展生存率 (PFS) 作为主要终点.
主要方法:
- 一个第2阶段,多中心,开放标签,单臂临床试验招募了41名先前未接受过治疗的患有晚期FH缺乏RCC的患者.
- 患者每3周内接受静脉注射的sintilimab,以及每天两次口服的axitinib,直到疾病进展或毒性.
- 主要终点包括ORR和PFS,次要终点评估安全性,整体存活率和疾病控制率.
主要成果:
- 客观反应率 (ORR) 为56% (95% CI,40%-72%),没有达到反应的中位持续时间.
- 无进展生存 (PFS) 的中位数为19.8个月 (95% CI,10.9个月至NR).
- 3级或更高的与治疗相关的不良事件发生在32%的患者中,最常见的是高甘油三血症 (7%).
结论:
- 辛蒂利马布和阿克西替尼的组合显示出令人鼓舞的疗效,在高级FH缺乏RCC中具有高ORR和长期PFS.
- 治疗方案显示了可管理的安全性,这表明它是一个可行的治疗选择.
- 随机临床试验的进一步验证是有必要的,以证实这些发现.
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