Open-label, Single-arm, Multicenter Phase II Study of Nimotuzumab Injection Combined With Sintilimab and Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma
This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.
⁃ All of the following participants will be enrolled in this trial:
• Patients voluntarily joined the study, signed informed consent, good compliance and follow-up.
• unresectable locally advanced, unresectable recurrent or metastatic ESCC confirmed by histopathology (excluding mixed adenosquamous cell carcinoma type);
• Patients who have not received previous systemic treatment, or have received previous (new) adjuvant treatment / radical treatment regimen (including radical surgical resection and radical chemoradiotherapy regimen) after recurrence for more than 6 months; Note: Including patients with reprogression after radiotherapy alone in late or recurrent non-target lesions. End of palliative treatment time to enrollment time of\> 2 weeks for local lesions (non-target lesions);
• Have at least one measured lesion according to the efficacy evaluation criteria of solid tumors version RECIST 1.1;
• Male or female patients between the ages of 18 and 75;
• Physical condition (PS) score of Eastern Oncology Cooperative Group (ECOG): 0-1;
• The survival period is expected to exceed 3 months;
• Having adequate organ and bone marrow function, that is, meeting the following criteria:
• A) Routine blood test criteria required (14, no blood transfusion and blood products within days, no correction with G-CSF and other hematopoietic stimulating factors):
• Hemoglobin content (HB): 100g / L; Leukocyte content (WBC) 3.0\*10\^9 / L; Neutrophil count (ANC) 1.5\*10\^9 / L; Platelet count (PLT) of 75\*10\^9 / L.
• B) Biochemical examination shall meet the following standards:
• Total serum bilirubin (TBIL) 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5ULN; ALT and LT AST 5 ULN; Cr≤1.5ULN Or creatinine clearance (CCr) 60 ml/min; (Cockcroft-Gault formula) C) Full coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) 1.5 times ULN; And d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) low normal value (50%); E) myocardial zymogram: within the normal range.
• Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after the cessation of study treatment, and they must be non-lactating patients. Before starting administration, the pregnancy test was negative or no risk of pregnancy was demonstrated by meeting one of the following criteria:
⁃ A) Postmenopause was defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; B) Women younger than 50 years old can also be considered postmenopausal if amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicular stimulating hormone (FSH) levels are within the range of laboratory postmenopausal reference values; And c) had ever undergone irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy or bilateral tubal resection, except for bilateral tubal ligation. For men, give consent to appropriate contraception or surgical sterilization during the trial and 8 weeks after the last dose of trial drug;