Abstract Background Camrelizumab has been verified as a standard therapy for advanced esophageal squamous cell carcinoma (ESCC). This study aimed to evaluate the efficacy and safety of neoadjuvant therapy with camrelizumab plus paclitaxel and nedaplatin in patients with locally advanced ESCC. Methods In this single-arm, phase II study, patients with stage IIa-IIIb ESCC were enrolled and received camrelizumab (200 mg), paclitaxel (155 mg/m2), and nedaplatin (80 mg/m2) intravenously on day one every 3 weeks. Patients underwent surgery after 2–4 cycles of treatment. The primary endpoint was pathological complete remission (pCR) rate, and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), overall survival (OS) and safety. Results Among the 62 patients who underwent surgery, the ORR was 48.4%, and the DCR was 98.4%. The pCR rate was 27.4%, and the MPR rate was 45.2%. Additionally, 39 patients (62.9%) achieved stage T downstaging, and 19 (30.6%) achieved nodal downstaging. The median OS for surgical patients was not reached, with 1-year, 2-year, 3-year, and 4-year OS rates of 98.4%, 91.6%, 89.8%, and 83.4%, respectively. And the 1-year, 2-year, 3-year, and 4-year DFS rates were 93.5%, 80.2%,70.8%, and 64.3%, respectively. Treatment related adverse events (TRAEs) were observed in 59 patients (78.7%), including grade 3–4 TRAEs in 5 patients. Conclusion The ESPRIT study indicates that camrelizumab combined with paclitaxel and nedaplatin as neoadjuvant therapy is well tolerated, effectively reducing tumor size and stage. This regimen also demonstrates favorable outcomes in overall survival and significantly extends disease-free survival. These promising results support the continued investigation of this treatment approach.
Ma et al. (Fri,) studied this question.