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A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:
A Prospective, Open-label, Randomized, Phase II Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy Versus Chemotherapy in Perioperative Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma (ECTOP-2006).

Clinical Trial Summary

This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.

Clinical Trial Description

This study was designed as an open-label, randomized controlled, phase II trial. Subjects will be systematically randomized at a ratio of 1:1 and will be assigned to either the experimental group (sintilimab combined with chemotherapy group) or the control group (chemotherapy alone group). They will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators. The primary endpoint is 1-year Event-free survival (EFS) rate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06152978
Study type Interventional
Source Fudan University
Contact Haiquan Chen, MD
Phone +86 13601973588
Email hqchen1@yahoo.com
Status Not yet recruiting
Phase Phase 2
Start date December 15, 2023
Completion date December 15, 2027
View Details
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