Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

Official record

Identifier

NCT07629817

Recruiting locations

country

China

Interventions studied

Toripalimab + Nab-paclitaxel + Platinum-based ChemotherapyRadiation with Concurrent ChemotherapyRadical Esophagectomy

Lead sponsor

Henan Cancer Hospital

Target enrolment

1044 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Jun 5, 2026

Last updated on the registry

Jul 31, 2026

Age

18 Years – 75 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.