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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,044
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, any sex.
- •ECOG Performance Status 0-
- •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).
排除标准
- •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.
研究组 & 干预措施
Organ Preservation with Radical Chemoradiotherapy
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.
干预措施: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy (Drug)
Immediate Esophagectomy
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+).
干预措施: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy (Drug)
Immediate Esophagectomy
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+).
干预措施: Radical Esophagectomy (Procedure)
Non-Responder Surgery
Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings.
干预措施: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy (Drug)
Non-Responder Surgery
Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings.
干预措施: Radical Esophagectomy (Procedure)
Organ Preservation with Radical Chemoradiotherapy
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.
干预措施: Radiation with Concurrent Chemotherapy (Combination Product)