A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer
This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma.
• Subjects voluntarily enrolled in this study, signed the informed consent form, had good compliance, and could cooperate with follow-up visits;
• esophageal cancer diagnosed by histopathology; clinical staging of cT1b-cT2 N+ M0 or cT3, any N, M0 (according to AJCC 8th edition);
• Age 18-75 years old, male or female;
• ECOG PS 0-1;
• measurable tumor lesions or non-measurable lesions that can be evaluated;
• not having received any previous anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc;
• Normal or mildly to moderately abnormal lung function (VC%\>60%, FEV1\>1.2L, FEV1%\>40%, DLco\>40%) that can tolerate esophageal cancer resection;
• No contraindications to surgery;
• function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): (1) Normal bone marrow reserve function with white blood cell (WBC) ≥3.0×109/L; neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L; (2) Normal renal function with serum creatinine (SCr) ≤1.5 times upper limit of normal (ULN) or creatinine clearance ≥60 ml/min (Cockcroft-Gault formula); (3) Normal liver function with total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); and an albumin transaminase (AST) or alanine transaminase (ALT) level ≤2.5 times the upper limit of normal (ULN); (4) Normal coagulation function with International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN).
⁃ Patients with potential childbearing potential are required to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) during and for 6 months after the end of the study treatment period; must have had a negative serum HCG or urine HCG test for 72 h prior to study entry; and must not be breastfeeding.