Spots Global Cancer Trial Database for A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
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Trial Identification
Brief Title: A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
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).
Study ID: NCT06152978
Conditions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Haiquan Chen, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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