Definitive Concurrent Chemoradiotherapy Versus Surgery in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ESCC) Who Achieve Complete or Partial Response After Neoadjuvant Chemo-immunotherapy: A Two-arm Phase II Clinical Study (SORT Trial)
This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant chemo-immunotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2-3 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.
• Volunteered to participate, cooperated with follow-up visits.
• Aged 18 - 75 years (inclusive), male or female.
• Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR/PR after 2-3 cycles of platinum-based chemotherapy combined with anti-PD-1 or PD-L1 monoclonal antibodies.
• Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Estimated survival time ≥ 3 months.
• The function of major organs meets the following requirements:
‣ Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
⁃ Platelets ≥ 80×10\^9/L;
⁃ Hemoglobin ≥ 9g/dL;
⁃ Serum albumin ≥ 2.8g/dL;
⁃ Total bilirubin ≤ 1.5 × ULN, ALT, AST and/or ALP ≤ 2.5 × ULN;
⁃ Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60mL/min;
⁃ International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5× ULN (subjects on stable doses of anticoagulation therapy, such as low molecular weight heparin or warfarin, and with INR within the expected therapeutic range of the anticoagulant can be screened);
• Comprehensive baseline staging evaluation prior to induction chemo-immunotherapy, including esophagogastroduodenoscopy (with biopsy) and/or endoscopic ultrasonography (EUS), contrast-enhanced CT of the neck, chest, and upper abdomen (with or without PET-CT), magnetic resonance imaging (MRI) without MRI contraindications, and upper gastrointestinal contrast.
• Patients of childbearing potential must use a medically approved contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study treatment period and within 6 months after the end of the study treatment; serum Human Chorionic Gonadotropin (HCG) or urine HCG test must be negative within 72 hours before study enrollment; and must not be breastfeeding.