新辅助剂sintilimab和化学治疗可切除的食道状细胞癌:一个II期临床试验
Jincheng Guo1, Chengrui Qiao1, Jiabin Lu1
1Department of Thoracic Surgery, The First Affiliated Hospital of Henan Polytechnic University, Jiaozuo, Henan, China.
辛提利马布加化学疗法作为可切除食道状细胞癌 (ESCC) 的新辅助治疗方法具有前景,达到28.6%的病理完整反应率,并具有可控的副作用.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 胃肠道癌症研究研究
背景情况:
- 转移性食道状细胞癌 (ESCC) 通常用抗PD-1抗体和化疗治疗.
- 这种组合对可切除ESCC的新辅助疗效尚未得到充分研究.
研究的目的:
- 评估Sintilimab加化疗作为可切除ESCC的新辅助疗法.
- 评估这种组合治疗方案的安全性和有效性.
主要方法:
- 可切除ESCC的单臂II期研究 (II-III期).
- 在两次循环中,与nab-paclitaxel和cisplatin一起使用sintilimab.
- 主要终点:病理完整反应 (pCR).
主要成果:
- 观察到28.6%的pCR率 (6/21) 和42.9%的主要病理反应 (MPR) 率 (9/21).
- 最常见的3/4级不良事件:白血病 (26.7%) 和中性病 (20%).
- 没有报告与治疗相关的手术并发症或延迟.
结论:
- 辛提利马布加化疗是一种可容忍的ESCC新辅助疗法.
- 显示出良好的反应率,提供可行的替代治疗方法.
- 对于中国患者群体来说尤其重要.
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