A Prospective, Randomized Controlled, Open Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy in Elderly Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.
• The subject volunteered to join the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
• Age 70 or above, male or female;
• The ECOG score is 0-1 point;
• Oesophageal squamous cell carcinoma diagnosed by histology or cytology;
• According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one measurable lesion, and the measurable lesion should not receive local treatment such as radiotherapy (the lesion located in the previous radiotherapy area can also be selected if the progression is confirmed and meets the RECIST1.1 criteria);
• Stage II-IVB (IVB stage only includes supraclavicular/abdominal lymph node metastasis, does not include any other distant metastasis), can tolerate synchronous radiotherapy, chemotherapy, and targeted therapy
• Expected survival time of 6 months;
• Main organ function is normal, that is, meet the following criteria:
⁃ 1\) Blood routine examination:
• HBG≥90g/L;
• ANC≥1.5×109/L;
• PLT ≥80×109/L; 2) Biochemical examination:
⁃ a.ALB≥30g/L; B. ALT and AST≤2.5ULN; ALT and AST 5 ULN; c.TBIL≤1.5ULN; D. Plasma Cr≤1.5ULN or creatinine clearance (CCr) of 60 ml/min; 9. Echocardiographic assessment: left ventricular ejection fraction (LVEF) low normal value (50%); 10. Women of childbearing age should agree to use contraception (e. g. intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; serum or urine pregnancy tests were negative within 7 days before study enrollment and must be non-lactating patients; men who agree to use contraception during the study and within 6 months after the end of the study period.