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.
Age 18-75 years, any sex.
ECOG Performance Status 0-1.
Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.
History of other malignancy within the past 5 years.
Active autoimmune disease.
Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection.
Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction < 50%, Forced Expiratory Volume in 1 second < 1 L).
Parallel
Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
DrugThis 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
Combination productChemotherapy administered concurrently with radiotherapy
Radical Esophagectomy
Procedure/SurgeryStandard 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
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