Safety and Efficacy of Camrelizumab Combined With Radiotherapy as Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Abstract Background Neoadjuvant chemoradiotherapy followed by esophagectomy is the standard of care for locally advanced esophageal squamous cell carcinoma (ESCC). However, approximately 30% of patients still develop distant metastases and have a high incidence of treatment-related adverse events. Immunotherapy, as a new modality for anti-cancer treatment, has shown promising clinical benefits for patients with ESCC. The synergistic effects of immunotherapy and radiotherapy make their combination promising as neoadjuvant treatment for locally advanced ESCC. Therefore, we conducted a single-arm, prospective phase II trial to investigate the safety and efficacy of Camrelizumab combined with radiotherapy as neoadjuvant therapy for resectable ESCC. Methods Patients with thoracic segment esophageal cancer with clinical stage T2–3 N0 M0 or T2–3 N+ M0 will be included. They will be treated with radical surgery within 4–8 weeks after the completion of two cycles of neoadjuvant radiotherapy in combination with camrelizumab. The primary endpoint is the major pathological remission rate of all per-protocol patients. The secondary endpoints are the R0 resection rate, pathological complete remission rate, and adverse events. The interim analysis will be conducted after half of the planned number of patients have been enrolled. Results A total of 25 patients were enrolled, 3 patients did not undergo surgery, of which 1 had imaging CR after neoadjuvant therapy and refused surgical treatment; 1 progressed during neoadjuvant therapy, and the other had immune pneumonitis and renal insufficiency during neoadjuvant therapy. The final results of the study noted that of the 22 patients who underwent surgery, the R0 resection rate was 90.1%, the postoperative pCR rate was 40%, and the MPR rate was 65%. Conclusion Neoadjuvant Camrelizumab combined with radiotherapy for resectable esophageal squamous carcinoma is safe and feasible with favorable MPR rates and low incidence of treatment-related adverse events.