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A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy
Sponsor: Henan Cancer Hospital
Summary
This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1044
Start Date
2026-06-15
Completion Date
2032-03-15
Last Updated
2026-06-05
Healthy Volunteers
No
Conditions
Interventions
Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
Radiation with Concurrent Chemotherapy
Chemotherapy administered concurrently with radiotherapy
Radical Esophagectomy
Standard surgical procedure with lymph node dissection