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NCT05357846 · ClinicalTrials.gov record · last posted 2026-04-30

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

StatusRecruiting
PhasePhase 3
Started2022-11-01
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from the ClinicalTrials.gov record
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2022-05-01; most recent amendment 2026-04-24. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2022-11-11
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT05357846
Lead Sponsor Sun Yat-sen University
Collaborators: Affiliated Cancer Hospital of Shantou University Medical College
Conditions Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer
Enrollment 422 participants
Start Date 2022-11-01
Primary Completion 2031-01-01 (estimated)
Study Completion 2031-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-30