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Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 3
Started2022-08-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 2, 2024 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-10-01
Active, Not Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusActive, Not Recruiting→Recruiting
Study sites1→2
2022-08-08
Original filing
No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph node metastasis following initial surgery for esophageal squamous cell carcinoma (ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical T1-2 N0 patients with incidental pathologic lymph node metastasis following initial surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally advanced ESCC, we initiated this randomized controlled trial (RCT).
Trial Details
NCT Number NCT05495152
Lead Sponsor Henan Cancer Hospital
Conditions Esophageal Squamous Cell Carcinoma
Enrollment 219 participants
Start Date 2022-08-01
Primary Completion 2025-08-31 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-02