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

Author:

Sun Hai-Bo1ORCID,Xing Wen-Qun1,Liu Xian-Ben1,Yang Shu-Jun2,Chen Pei-Nan1,Liu Shi-Lei1,Li Peng1,Ma Ya-Xing1,Jiang Duo1,Yan Sen1

Affiliation:

1. Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, China

2. Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, 450008, China

Abstract

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 ( NCT05495152 ). 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. Clinical Trial Registration: NCT05495152 ( ClinicalTrials.gov )

Funder

Health Commission of Henan Province

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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