Clinical trial · Interventional
Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation with Concurrent Chemotherapy | Combination Product | — | UNRESOLVED |
| Radical Esophagectomy | Procedure | — | UNRESOLVED |
| Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Organ Preservation with Radical Chemoradiotherapy
- description
- Patients achieving clinical complete or partial response (cCR/cPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy/28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy.
- interventionNames
- Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
- Combination Product: Radiation with Concurrent Chemotherapy
- type
- EXPERIMENTAL
- label
- Immediate Esophagectomy
- description
- Patients achieving cCR/cPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available