Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCESO1 trial

Recent single-arm studies of neoadjuvant camrelizumab (PD-1 inhibitor) plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) showed promising results. This multicenter, randomized, open-label phase 3 trial compared neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab versus neoadjuvant chemotherapy alone. A total of 391 patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were randomized 1:1:1 to camrelizumab+albumin-bound paclitaxel+cisplatin (Cam+nab-TP; n=132), camrelizumab+paclitaxel+cisplatin (Cam+TP; n=130), or paclitaxel+cisplatin (TP; n=129), then surgery; Cam arms also received adjuvant camrelizumab. Dual primary endpoints were pathological complete response (PCR, by blinded independent review committee) and event-free survival (EFS, by investigators). This report presents final PCR results. In the intention-to-treat population, PCR rates were 28.0% (Cam+nab-TP) and 15.4% (Cam+TP) versus 4.7% (TP) (Cam+nab-TP vs TP: difference 23.5%, 95% CI 15.1–32.0, P<0.0001; Cam+TP vs TP: difference 10.9%, 95% CI 3.7–18.1, P=0.0034). EFS is not yet mature. Grade ≥3 treatment-related adverse events during neoadjuvant therapy occurred in 34.1%, 29.2%, and 28.8%, respectively; postoperative complication rates were 34.2%, 38.8%, and 32.0%. Neoadjuvant camrelizumab plus chemotherapy improved PCR versus chemotherapy alone with acceptable safety. ChiCTR2000040034.