Definitive Concurrent Chemoradiotherapy Versus Surgery in Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma (ESCC) Who Achieve Complete or Partial Response After Neoadjuvant Camrelizumab Combined With Chemotherapy: A Single-arm Phase II Clinical Study (SORT Trial)
This is a single-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 camrelizumab combined with chemotherapy. A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2 cycles of induction chemoimmunotherapy (camrelizumab + nab-paclitaxel + carboplatin) 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 cycles of camrelizumab combined with nab-paclitaxel and carboplatin.
• Presence of measurable and/or non-measurable lesions as defined by RECIST 1.1;
• 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);
• 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.