Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China.
Department of Radiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
BMC Cancer. 2022 May 6;22(1):506. doi: 10.1186/s12885-022-09573-6.
Preoperative chemoradiotherapy (CRT) with CROSS regimen has been the recommended treatment for locally advanced esophageal squamous cell carcinoma (ESCC). The addition of programmed cell death protein 1 (PD-1) inhibitor to preoperative CRT may further improve oncologic results. Preoperative camrelizumab plus chemotherapy has been demonstrated as a promising treatment modality based on results of the phase II NICE study (ChiCTR1900026240).
The NICE-2 study is designed as a three-arm, multicenter, prospective, randomized, phase II clinical trial, comparing camrelizumab plus chemotherapy (IO-CT) and camrelizumab plus CRT (IO-CRT) versus CRT as preoperative treatment for locally advanced ESCC. A total of 204 patients will be recruited from 8 Chinese institutions within 1.5 years. The primary endpoint is pathological complete response (pCR) rate and secondary endpoints include event-free survival (EFS), R0 resection rate, and adverse events.
This is the first prospective randomized controlled trial to explore commonly used neoadjuvant treatments in clinical practice, which will provide high-level evidence of neoadjuvant treatment for patients with locally advanced ESCC. The purpose of this study is to establish the optimal modality of IO-CT, IO-CRT and CRT as preoperative treatment for locally advanced ESCC. The Institution Review Committee approved this study protocol in August 2021 and patient enrollment was started in September 2021.
ClinicalTrial.gov: NCT05043688 (August 29, 2021). The trial was prospectively registered.
CROSS 方案的术前放化疗已被推荐用于局部晚期食管鳞癌（ESCC）的治疗。在术前 CRT 中加入程序性死亡蛋白 1（PD-1）抑制剂可能会进一步提高肿瘤学疗效。基于 NICE 研究（ChiCTR1900026240）的结果，术前卡瑞利珠单抗联合化疗已被证明是一种很有前途的治疗方法。
NICE-2 研究设计为一项三臂、多中心、前瞻性、随机、Ⅱ期临床试验，比较卡瑞利珠单抗联合化疗（IO-CT）和卡瑞利珠单抗联合 CRT（IO-CRT）与 CRT 作为局部晚期 ESCC 的术前治疗。在 1.5 年内，将从 8 家中国机构招募 204 名患者。主要终点是病理完全缓解（pCR）率，次要终点包括无事件生存（EFS）、R0 切除率和不良事件。
这是第一项探索临床实践中常用新辅助治疗的前瞻性随机对照试验，将为局部晚期 ESCC 患者提供新辅助治疗的高级别证据。本研究的目的是确定 IO-CT、IO-CRT 和 CRT 作为局部晚期 ESCC 术前治疗的最佳模式。机构审查委员会于 2021 年 8 月批准了该研究方案，2021 年 9 月开始入组患者。
ClinicalTrials.gov：NCT05043688（2021 年 8 月 29 日）。试验前瞻性注册。
