Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
• male or female
• Age ≥ 18 years old
• Pathological confirmation of esophageal squamous cell carcinoma
• Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
• No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
• Tumor longitudinal diameter ≤ 10cm
• The tumor did not involve the dentate line
• ECOG score 0 or 1
• No hematological diseases, no liver or kidney dysfunction
• Absolute neutrophil count ≥ 1.5 × 109/L
• Platelets ≥ 100 × 109/L
• Hemoglobin ≥ 11g/L
• ALT ≤ 2 times the upper limit of normal value
• TBil ≤ 1.5 times the upper limit of normal value
• Creatinine clearance rate (Cockroft) ≥ 50ml/min
• Obtain informed consent