esophageal squamous cell carcinoma
Conditions
Interventions
treatment group:neoadjuvant chemo-immunotherapy
Sponsors
Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age: =70 years (no age limit, with super-elderly patients, such as those =80 years, the investigator will assess whether to include them based on the actual situation; gender is not restricted). (2) ECOG PS: 0-1 points; and G8 score =14 points. (Patients with G8 scores <14 points will undergo Comprehensive Geriatric Assessment (CGA), and the investigator will decide on inclusion based on the assessment results). (3) Pathologically confirmed esophageal squamous cell carcinoma. (4) No history of prior anti-tumor treatment. (5) Clinical stage is T2-4aN0M0 or T1-4aN+M0, and MDT evaluation deems the patient operable (AJCC staging eighth edition). (6) Adequate organ function: - Hematological tests (within 7 days, without the use of hematopoietic growth factors and transfusion): 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), blood 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). If the subject is receiving anticoagulant therapy, PT within the designated range of anticoagulant drugs is acceptable. - Cardiac function assessment: Normal electrocardiogram or an abnormal electrocardiogram (deemed clinically insignificant by the investigator); cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) =50%. (7) Willing to voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: (1) Concurrent presence of other malignant tumors. (2) Active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after normal hormone replacement therapy). (3) Uncontrollable severe systemic diseases (involving the central nervous system, cardiovascular system, hematological system, digestive system, endocrine system, respiratory system, urogenital system, immune system, etc.) and patients with mental illness. (4) Severe cardiovascular events: heart failure (NYHA III-IV), myocardial infarction, unstable angina, severe arrhythmia, stroke, or cerebral hemorrhage within the last 6 months. (5) Congenital or acquired immunodeficiency (such as 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 analysis method). (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 |
|---|---|
| Pathological complete response rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| one-year Disease-free-survival rate;Pathological Tumor Regression Rate;Surgical Completion Rate;R0 resection rate;Incidence of Adverse events to Neoadjuvant and Surgical Treatment; | — |
Countries
China
Contacts
Public ContactZhenyu Ding
Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University
Outcome results
None listed