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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,044
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel
Chemotherapy administered concurrently with radiotherapy
Standard surgical procedure with lymph node dissection
3-year Event-Free Survival (EFS) Rate
Event-Free Survival is defined as the time from randomization (for responders) or from the start of neoadjuvant therapy (for the overall population) until the occurrence of any of the following events: Local recurrence of esophageal cancer. Distant metastasis. Death from any cause
Time frame: 3 years after randomization/treatment initiation
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