Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy, Radiation with Concurrent Chemotherapy, Radical Esophagectomy.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy
Overview
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.
Interventions
- Drug Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel - Combination product Radiation with Concurrent Chemotherapy
Chemotherapy administered concurrently with radiotherapy - Procedure Radical Esophagectomy
Standard surgical procedure with lymph node dissection
Primary outcome measures
- 3-year Event-Free Survival (EFS) Rate [Time frame: 3 years after randomization/treatment initiation]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Henan Cancer Hospital — Zhengzhou
Identifiers
NCT: NCT07629817 · 2026-150