Multicenter phase 2 randomized trial of neoadjuvant camrelizumab plus chemotherapy versus chemoradiotherapy for resectable ESCC

The multicenter, randomized, open-label, phase 2 noninferiority REVO trial in China assessed the efficacy and safety of neoadjuvant camrelizumab plus nab-paclitaxel and cisplatin chemotherapy (nICT; n=52) compared with standard neoadjuvant nab-paclitaxel and cisplatin plus radiotherapy (nCRT; n=52) in patients with resectable, locally advanced esophageal squamous cell carcinoma (LA ESCC). The primary endpoint was pathologic complete response (pCR). The pCR rate was 32.7% with nICT versus 34.6% with nCRT (rate ratio 0.94; 90% CI 0.6-1.49), demonstrating non-inferiority and meeting the prespecified primary endpoint. Major pathologic response was observed in 42.3% of nICT patients and 57.7% of nCRT patients, with R0 resection achieved in 100% of both groups. One-year disease-free survival rate was 89.1% versus 78.2%, and one-year overall survival rate was 100% versus 92.3% for nICT and nCRT, respectively. Grade ≥ 3 treatment-related adverse events occurred in 19.2% of nICT patients and 33.3% of nCRT patients, and surgical complications were reported in 31.1% and 35.9%, respectively. The authors conclude that ICT is a safe and effective neoadjuvant strategy for resectable ESCC, with a more favorable safety profile than nCRT.