A multicenter randomized, controlled clinical trial of adjuvant sintilimab for esophageal squamous cell carcinoma

No adjuvant treatment has been established for patients who remain at high risk of recurrence and incidental pathologic lymph node metastasis for esophageal squamous cell carcinoma (ESCC). In this open-label, multicenter, phase III, randomized controlled trial, ESCC patients who did not achieve path...

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Bibliographic Details
Published in:Future oncology (London, England) England), 2023-08, Vol.19 (26), p.1777-1784
Main Authors: Sun, Hai-Bo, Xing, Wen-Qun, Liu, Xian-Ben, Yang, Shu-Jun, Chen, Pei-Nan, Liu, Shi-Lei, Li, Peng, Ma, Ya-Xing, Jiang, Duo, Yan, Sen
Format: Article
Language:English
Subjects:
adjuvant immunotherapy
esophageal squamous cell carcinoma
sintilimab
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Summary:No adjuvant treatment has been established for patients who remain at high risk of recurrence and incidental pathologic lymph node metastasis for esophageal squamous cell carcinoma (ESCC). In this open-label, multicenter, phase III, randomized controlled trial, ESCC patients who did not achieve pathologic complete response after neoadjuvant chemotherapy plus surgery and clinical T1–2 N0 patients with incidental pathologic lymph node metastasis following initial surgery were randomized at a 2:1 ratio to receive either a sintilimab regimen or observational management ( ). The primary end point was disease-free survival for all randomized patients. The results of this randomized controlled trial addressed controversy regarding the survival benefits of adjuvant sintilimab treatment for patients with resected locally advanced ESCC. : ( )
ISSN:1479-6694
1744-8301
DOI:10.2217/fon-2022-1255