A Multicenter Randomized, Controlled Clinical Trial of Adjuvant Sintilimab for Esophageal Squamous Cell Carcinoma

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)

Keywords::

• adjuvant immunotherapy
• esophageal squamous cell carcinoma
• sintilimab

Author contributions

HB Sun, XB Liu and WQ Xing made substantial contributions to the conception and design of this protocol. HB Sun, SJ Yang, SL Liu, PN Chen, P Li, YX Ma, D Jiang and S Yan were responsible for drafting the manuscript. HB Sun, XB Liu, SJ Yang, SL Liu, PN Chen, P Li and YX Ma, were responsible for revising it critically for important intellectual content. All authors read and gave their final approval of the version to be published.

Financial disclosure

This study was funded by the Talent Youth Project of Henan Youth Health Science and Technology Innovation Foundation (YXKC2020022). HCHTOG2203 is supported by a governmental funding body. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

This study was funded by the Talent Youth Project of Henan Youth Health Science and Technology Innovation Foundation (YXKC2020022). HCHTOG2203 is supported by a governmental funding body. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.