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Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

RecruitingPhase 3Ages 18 Years - 75 YearsAllHenan Cancer Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
  • Radiation with Concurrent Chemotherapy
  • Radical Esophagectomy
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Where

1 site
Henan Cancer Hospital
Zhengzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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