Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study)
Yang Yang,
Li Zhu,
Yan Cheng,
Zhichao Liu,
Xiaoyue Cai,
Jinchen Shao,
Ming Zhang,
Jun Liu,
Yifeng Sun,
Yin Li,
Jun Yi,
Bentong Yu,
Hongjing Jiang,
Hezhong Chen,
Hong Yang,
Lijie Tan,
Zhigang Li
Affiliations
Yang Yang
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University
Li Zhu
Department of Radiology, Shanghai Chest Hospital, Shanghai Jiao Tong University
Yan Cheng
Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University
Zhichao Liu
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University
Xiaoyue Cai
Department of Integrative Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University
Jinchen Shao
Department of Pathology, Shanghai Chest Hospital, Shanghai Jiao Tong University
Ming Zhang
Department of Integrative Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University
Jun Liu
Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University
Yifeng Sun
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University
Yin Li
Department of Thoracic Surgery, Cancer Hospital Chinese Academy of Medical Sciences
Jun Yi
Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University
Bentong Yu
Department of Thoracic Surgery, The First Affiliated Hospital of Nanchang University
Hongjing Jiang
Department of Thoracic Surgery, Tianjin Medical University Cancer Hospital
Hezhong Chen
Department of Thoracic Surgery, Changhai Hospital Affiliated to The Second Military Medical University
Hong Yang
Department of Thoracic Surgery, Sun Yat-Sen University Cancer Center
Lijie Tan
Department of Thoracic Surgery, Zhongshan Hospital Affiliated to Fudan University
Zhigang Li
Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University
Abstract Background 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). Methods 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. Discussion 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. Trial registration ClinicalTrial.gov: NCT05043688 (August 29, 2021). The trial was prospectively registered.
