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Recruiting
NCT07629817
Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
Conditions: Esophageal Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1044
Sponsor: Henan Cancer Hospital
Location: Henan Cancer Hospital Zhengzhou Henan
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07629817). StuddyBuddy aggregates publicly available trial information.