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).
Henan Cancer Hospital
Lead sponsor