新辅助化学放射疗法加上顺序性tislelizumab,然后对食道癌进行手术 (CRISEC研究):单臂,双中心,第二阶段试验
Jinsong Yang1, Cui Liu2, Zhigang Zuo3
1Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China; Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China.
概括
新辅助化学放射疗法加上连续的tislelizumab在食道状细胞癌 (ESCC) 患者中证明了安全性和可行性. 需要进一步的研究来证实这种治疗组合的疗效.
科学领域:
- 在瘤学瘤学.
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 食道状细胞癌 (ESCC) 在治疗中提出了重大挑战,需要新的治疗策略.
- 新辅助化学辐射疗法 (NCRT) 是一种标准方法,但其与新型免疫疗法的结合正在研究中.
研究的目的:
- 评估新辅助化疗放射治疗 (NCRT) 的疗效和安全性,然后在可切除或可能切除ESCC的患者中进行连续的tislelizumab.
- 评估病理完整反应 (pCR) 率作为主要终点.
主要方法:
- 进行了一项单臂,双中心的2期临床试验.
- 患者接受了新辅助性放射治疗 (41.4 Gy) 与并发化疗 (与白结合的帕克利塔塞尔和卡博普拉丁),随后进行了三轮提斯莱利祖马布治疗.
- 在治疗后进行了手术,终点包括pCR,R0切除,主要病理反应 (MPR),安全性,无病生存 (DFS) 和整体生存 (OS).
主要成果:
- 在30名注册患者中,有24名 (80.0%) 完成了R0切除 (100%) 的手术.
- 病理完整反应 (pCR) 在37.5%的患者中实现,主要病理反应 (MPR) 在87.5%中实现.
- 两年总生存率 (OS) 和无病生存率 (DFS) 分别为83.3%和79.2%. 在tislelizumab治疗期间,35.7%的患者观察到3-4级毒性.
结论:
- 在ESCC中,在NCRT后连续给予tislelizumab是一种安全和可行的治疗策略.
- 组合疗法显示出有希望的疗效,需要进一步研究.
- 建议进行额外的研究,以验证这种联合治疗方法的有效性.
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