Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, multicenter, open-label randomized trial comparing organ-preserving strategies to radical esophagectomy in patients with resectable thoracic esophageal squamous cell carcinoma who achieved a complete or partial clinical response after neoadjuvant immunochemotherapy. Eligible participants are adults 18-75 with good performance status and adequate organ function, and disease meeting specific clinical staging criteria. Participants are randomized to receive either the neoadjuvant immunochemotherapy regimen with radiation and concurrent chemotherapy followed by organ-preserving treatment, or to proceed directly to radical esophagectomy. The trial aims to determine if less invasive approaches can achieve similar disease control while preserving esophageal anatomy and function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Yan Zheng, M.D./Ph.D
• Email: hnszlyylixiang@163.com
• Phone: (+86)0371-65587610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.