Toripalimab + Nab-paclitaxel + Platinum-based ChemotherapyRadiation with Concurrent ChemotherapyRadical Esophagectomy
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years, any sex.
2. ECOG Performance Status 0-1.
3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
4. 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.
5. Adequate bone marrow, hepatic, and renal function:
* Absolute neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L.
* Alanine aminotransferase / Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.
* Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL/min.
6. Signed written informed consent form (ICF).
Exclusion Criteria:
1. History of other malignancy within the past 5 years.
2. Active autoimmune disease.
3. Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection.
4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \< 50%, Forced Expiratory Volume in 1 second \< 1 L).
5. Pregnancy or lactation.
Primary outcome measure(s)
3-year Event-Free Survival (EFS) Rate — 3 years after randomization/treatment initiation 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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