Primary small cell carcinoma of esophagus
Conditions
Interventions
Experimental group:Neoadjuvant therapy (Serplulimab combined with paclitaxel + carboplatin)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years, both genders; (2) ECOG PS: 0-1 points; (3) Pathologically confirmed esophageal small cell carcinoma (including composite squamous cell carcinoma or adenocarcinoma); (4) No history of prior anti-tumor therapy; (5) Measurable tumor lesions (RECIST criteria); (6) Clinical stage T2-4N0M0 or TanyN+M0, and patients evaluated by surgery as eligible for operation (AJCC 8th edition staging); (7) Adequate organ function; - Complete blood count (not using hematopoietic growth factors or transfusion in the last 7 days): Granulocyte count =1.5×10^9/L, platelet count =80×10^9/L, hemoglobin =80g/L; - Biochemical tests: Total bilirubin =1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2.5×ULN; Creatinine clearance rate =60 mL/min (Cockcroft-Gault formula); - Coagulation function: INR or PT =1.5×ULN (upper limit of normal), and if the subject is receiving anticoagulant therapy, PT should be within the specified range of the anticoagulant drug. - Cardiac function assessment: Normal or clinically insignificant abnormal electrocardiogram; Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) =50%; (8) Voluntarily participate in this clinical study, sign the informed consent form, good compliance, and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: (1) Concurrent presence of other malignancies; (2) Presence of any active autoimmune disease or a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, or hypothyroidism (eligible after normalization with hormone replacement therapy); (3) Uncontrolled severe systemic diseases (such as central nervous system, cardiovascular system, hematologic system, digestive system, endocrine system, respiratory system, urinary-reproductive system, immune system, etc.) and patients with mental disorders; (4) Severe cardiovascular events: heart failure (NYHA III-IV class), myocardial infarction, unstable angina, severe arrhythmias, stroke, or cerebral hemorrhage within the last 6 months; (5) Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA = 10^4 copies/mL), or hepatitis C (positive HCV antibodies, and HCV-RNA higher than the detection limit of the assay); (6) Allergy or intolerance to the investigational drug; (7) Other conditions deemed unsuitable for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Overall Survival;objective response rate;Pathological complete response rate;Adverse events;Surgical completion rate;Pathological complete response rate; | — |
Countries
china
Contacts
Public ContactZhen-yu Ding
Department of Biological Therapy, West China Hospital, Sichuan University
Outcome results
None listed