PO.CT01.05 · 临床试验
信迪利单抗联合顺铂和白蛋白结合型紫杉醇诱导治疗局部晚期临界可切除食管鳞状细胞癌：一项单臂、前瞻性、2期研究（NEOCRTEC2001）
Sintilimab plus cisplatin and nab-paclitaxel induction treatment for locally advanced borderline resectable esophageal squamous cell carcinoma: A single-arm, prospective, phase 2 study (NEOCRTEC2001)
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作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
背景：由于临床试验证据不足，局部晚期临界可切除食管鳞状细胞癌（BR-ESCC）的标准治疗仍存在争议。越来越多的临床研究聚焦于探究免疫治疗在食管癌治疗中的应用。这项II期试验（NEOCRTEC-2001）旨在评估信迪利单抗联合顺铂和紫杉醇诱导免疫化疗后行手术治疗BR-ESCC的安全性和疗效。
患者与方法：NEOCRTEC2001试验是一项单中心、开放标签、非随机、II期研究。诊断为BR-ESCC的患者入组研究，首先接受2-4个疗程的诱导免疫化疗。后续治疗（手术或根治性放化疗）根据MDT重新评估结果确定。研究的主要终点为R0切除率。
结果：从2020年9月至2024年6月，共50例诊断为BR-ESCC的符合条件患者入组研究。所有符合条件的患者均接受诱导免疫化疗作为初始治疗。诱导免疫化疗后，50例患者中有35例（70.0%）被认为可切除，29例患者（58.0%）接受了手术。28例患者（56.0%，95% CI，41.4-69.1%）实现R0切除，9例患者（18.0%）达到病理完全缓解。8例患者（8/50，16.0%）观察到3级或更高级别的AEs。6例患者（6/29，20.69%）观察到3级或更高级别的术后并发症。R0切除组患者的总生存期（OS）和无进展生存期（PFS）显著优于非R0组（OS：未达到对19.84个月；HR 0.26；95%CI 0.07-0.95，p=0.005；PFS：未达到对19.82个月；HR 0.33；95%CI 0.10-1.11，p=0.02）。
结论：总之，本试验的主要终点未达到。尽管如此，诱导免疫化疗后行手术的治疗策略实现了显著的肿瘤降期和显著的病理完全缓解率。实现R0切除的患者表现出更好的生存结局。后续研究应聚焦于优化诱导治疗方案相关毒性的管理。
查看英文原文 English abstract
Background: The standard treatment for locally advanced borderline-resectable esophageal squamous cell carcinoma (BR-ESCC) is still debated owing to insufficient evidence from clinical trials. An increasing number of clinical studies focus on investigating the use of immunotherapy in the treatment of esophageal cancer. This phase II trial (NEOCRTEC-2001) aimed to assess the safety and efficacy of sintilimab in combination with cisplatin and paclitaxel induction immunochemotherapy followed by surgery for BR-ESCC.
Patients and methods: The NEOCRTEC2001 trial was a single-center, open-label, nonrandomized, phase II study. Patients diagnosed with BR-ESCC were enrolled in the study and initially received 2-4 courses of induction immunochemotherapy at first. The subsequent treatment, surgery or definitive chemoradiotherapy, was determined based on reassessment by MDT. The primary endpoint of the study was the R0 resection rate.
Results: From September 2020 to June 2024, a total of 50 eligible patients diagnosed with BR-ESCC were enrolled in the study. All eligible patients underwent induction immunochemotherapy as the initial treatment. After induction immunochemotherapy, 35 of 50 patients (70.0%) were considered resectable, and 29 patients (58.0%) underwent surgery. R0 resection was achieved in 28 patients (56.0%, 95% CI, 41.4 - 69.1%), and 9 patients (18.0%) achieved pathological complete response. AEs of Grade 3 or higher were observed in 8 patients (8/50, 16.0%). Postoperative complications of Grade 3 or higher were observed in 6 patients (6/29, 20.69%). Patients in the R0 resection group demonstrated significantly superior overall survival (OS) and progression-free survival (PFS) than those in the non-R0 group (OS: not reached vs. 19.84 months; HR 0.26; 95%CI 0.07-0.95, p=0.005; PFS: not reached vs. 19.82 months; HR 0.33; 95%CI 0.10-1.11 , p=0.02).
Conclusion: In conclusion, the primary endpoint of this trial has not been achieved. Nevertheless, the treatment strategy of induction immunochemotherapy followed by surgery resulted in significant tumor downstaging and a significant pathological complete response rate. Patients who achieved R0 resection exhibited improved survival outcomes. Subsequent studies should focus on optimizing the management of toxicity associated with induction therapy regimens.
利益披露 Disclosure
X. Zhang, None..
J. Wu, None..
D. Wang, None..
Z. Wang, None..
Q. Li, None..
C. Ren, None..
Y. Li, None..
H. Yang, None.