Neoadjuvant Chemoradiotherapy Plus Surgery vs. Surgery Plus Adjuvant Therapy for ESCC

Summary

This phase III randomized clinical trial compared the long-term survival and safety of neoadjuvant chemoradiotherapy (NCRT) followed by surgery versus surgery with adjuvant therapy (AT) in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Conducted at Sichuan Cancer Hospital, patients were randomly assigned to receive either NCRT (chemotherapy and radiotherapy followed by surgery) or AT (surgery followed by adjuvant therapy based on staging). The primary outcome was overall survival (OS), with secondary outcomes including disease-free survival (DFS), R0 resection rates, and treatment-related toxicity. A total of 245 patients were randomized, and 224 patients were included in the final analysis.

Timeline

Start

2018-01-01

Primary completion

2020-12-31

Completion

2024-07-31

Outcome

Missed primary endpoint

paper The 5-year OS rates were 59.2% (95% CI, 51.0%-68.8%) for the NCRT group and 59.6% (95% CI, 51.2%-69.5%) for the AT group (hazard ratio [HR], 1.01; 95% CI, 0.67-1.51; P = .97). PMID 41490111 ↗

Publications

• He W, Li Z, Xie Q, Han Y, Peng L, Wang C, Wang K, Liu G, Li H, Zhou Q, Li J, Zhang H, Xiao W, Fang Q, Miao Y, Leng X. Long-Term Survival Outcomes of NCRT With Surgery vs Surgery With Adjuvant Therapy for ESCC: A Single-Center Prospective Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2550307. doi: 10.1001/jamanetworkopen.2025.50307.

Drugs

Indications