Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

Summary

No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).

Timeline

Start

2022-08-01

Primary completion

2025-08-31

Completion

2028-08-31

Publications

• Sun HB, Xing WQ, Liu XB, Yang SJ, Chen PN, Liu SL, Li P, Ma YX, Jiang D, Yan S. A multicenter randomized, controlled clinical trial of adjuvant sintilimab for esophageal squamous cell carcinoma. Future Oncol. 2023 Aug;19(26):1777-1784. doi: 10.2217/fon-2022-1255. Epub 2023 Sep 22.

Drugs

Indications