A Study on Dynamic Monitoring of ctDNA in Neoadjuvant Therapy With Cetuximab Combined With Albumin-bound Paclitaxel and Nedaplatin for Esophageal Squamous Cell Carcinoma
This study is a prospective, multicenter, open-label, observational cohort study. The primary endpoint is pathological complete response (pCR), and the secondary endpoints include R0 resection rate, ctDNA clearance rate, major pathological response (MPR), recurrence-free survival (RFS), and overall survival (OS). Chinese patients with esophageal squamous cell carcinoma who are eligible for surgical resection will receive neoadjuvant therapy with cetuximab combined with albumin-bound paclitaxel and nedaplatin. Personalized ctDNA monitoring will be conducted at multiple time points, including before neoadjuvant therapy, during therapy, preoperatively, postoperatively, and during adjuvant therapy, to explore the clinical value of minimal residual disease (MRD) as a biomarker for assessing treatment efficacy, predicting recurrence risk, and evaluating prognosis in esophageal squamous cell carcinoma. This study aims to enroll 100 Chinese patients with stage II-III (potentially) resectable esophageal squamous cell carcinoma.
• Age between 18 and 70 years, regardless of gender.
• Patients with histologically confirmed clinical stage II-III thoracic esophageal squamous cell carcinoma.
• Neck enhanced CT scan showing no suspicious lymph node metastasis in the neck; no systemic metastasis detected by imaging examination.
• Expected to achieve R0 resection.
• ECOG performance status of 0-1.
• No prior anti-tumor treatment for esophageal cancer, including chemotherapy, radiotherapy (including planned radiotherapy during the study period), hormone therapy, and immunotherapy.
• Measurable lesions (according to RECIST v1.1 criteria).
• Preoperative evaluation of organ function shows no contraindications for surgery.
• Laboratory tests confirm good bone marrow, liver, kidney function, and coagulation function.
⁃ Able to provide informed consent and willing to cooperate with clinical follow-up.
⁃ Willing to provide peripheral blood samples for testing, as well as the patient's medical history, current treatment information, imaging studies, and tumor marker data, and willing to use the testing data for further scientific research, clinical diagnosis and treatment, and commercial product development.