Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

Recruiting now · Phase 3

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT07629817

Run by

Henan Cancer Hospital

People needed

1044

Starts

2026-06-16

Expected to finish

2032-03-15

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Signed written informed consent form (ICF).

You may not qualify if…

• 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).
• Pregnancy or lactation.

Where it is running

• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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