Neoadjuvant Ivonescimab and Chemotherapy in Resectable Esophageal Cancer

Inclusion Criteria:

1. Histologically confirmed primary esophageal squamous cell carcinoma, locallyadvanced, staging cT1N2M0, cT2-3N0-2M0 (stage II/III), AJCC 8th editionclinical staging of esophageal squamous cell carcinoma; 2) Surgical treatmentis possible; 3) ECOG score: 0 to 1; 4) The function of important organs meetsthe following requirements (excluding the use of any blood components and cellgrowth factors within 14 days): the subject has no dysfunction of major organs,and the blood routine, lung, liver, kidney function, and heart function arebasically normal. Laboratory laboratory test indicators must meet the followingrequirements: blood: white blood cells>4.0 × 109/L, absolute count ofneutrophils (ANC) ≥ 2.0 × 109/L, platelet count>100 × 109/L, hemoglobin>90g/L;Pulmonary function: FEV1 ≥ 1.2L, FEV1% ≥ 50%, and DLCO ≥ 50%; Liver function:serum bilirubin is below 1.5 times the maximum normal value; ALT and AST are 1.5 times lower than the maximum normal values. Renal function: Bloodcreatinine (SCr) ≤ 120 µ mol/L, creatinine clearance rate (CCr) ≥ 60 ml/min; 5)Before treatment, gastroscopy tissue and blood samples need to be collectedfrom our center; 6) The subjects voluntarily joined this study, showed goodcompliance, and cooperated with safety and survival follow-up.

Exclusion Criteria:

1. Previously received radiation therapy, chemotherapy, hormone therapy, surgery,or molecular targeted therapy; 2) Suspected cervical lymph node metastasis onimaging; The subject has a history or concurrent history of other malignanttumors (Excluding cured basal cell carcinoma of the skin and cervical carcinomain situ; 3) Previous PD-1/PD-L1 treatment history; 4) History of allergies tomacromolecular protein preparations or any PD-1 components; 5) Subjects withany active autoimmune disease or history of autoimmune disease (such as but notlimited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism,hypothyroidism; subjects with vitiligo or complete remission of childhoodasthma without any intervention in adulthood; subjects with asthma requiringmedical intervention with bronchodilators cannot be included); 6) The subjectis currently using immunosuppressive agents, systemic or absorbable localhormone therapy to achieve immunosuppressive effects (dose>10mg/day prednisoneor other therapeutic hormones), and has continued to use them within 2 weeksprior to enrollment; 7) Ascites or pleural effusion with clinical symptomsrequire therapeutic puncture or drainage; 8) Patients with uncontrolled cardiacclinical symptoms or diseases, such as: (1) NYHA grade 2 or above heartfailure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4)clinically significant supraventricular or ventricular arrhythmias requiringtreatment or intervention; 9) Abnormal coagulation function (PT>16s, APTT>43s,TT>21s, Fbg>2g/L), with bleeding tendency or undergoing thrombolytic oranticoagulant therapy; 10) The patient currently (within 3 months) hasdigestive tract diseases such as esophageal varices, active ulcers in thestomach and duodenum, ulcerative colitis, portal hypertension, or activebleeding from unresected tumors, or other conditions determined by theresearchers that may cause gastrointestinal bleeding or perforation; 11)Previous or current severe bleeding (bleeding>30 ml within 3 months),hemoptysis (fresh blood >5ml within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attacks) occurring within 12months; 12) The subject has an active infection or an unexplained fever >38.5℃during the screening period or before the first administration (according tothe researcher's judgment, subjects with fever caused by tumors can be includedin the group); 13) Having experienced abdominal fistula, gastrointestinalperforation, or abdominal abscess less than 4 weeks prior to medication; 14)Patients with objective evidence of past and current history of pulmonaryfibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis,drug-related pneumonia, severe impairment of lung function, etc; 15) Subjectswith congenital or acquired immune function defects, such as HIV infection, oractive hepatitis (transaminase does not meet the inclusion criteria, hepatitisB reference: HBV DNA ≥10^4/ml ； Hepatitis C reference: HCVRNA≥10^3/ml）； Chronichepatitis B virus carriers with HBV DNA<2000 IU/ml (<10^4 copies/ml) mustreceive antiviral treatment during the trial period in order to be enrolled;
2. The subjects are currently participating in other clinical studies or havebeen less than one month since the end of the previous clinical study;Participants may receive other systemic anti-tumor treatments during the studyperiod; 17) Medication less than 4 weeks before the study or may receive livevaccine during the study period; 18) The subject is known to have a history ofsubstance abuse, alcoholism, or drug use; 19) The subject is unable orunwilling to bear the self funded portion of the examination and treatmentcosts; 20) The researchers believe that the subjects should be excluded fromthis study, for example, if the researchers determine that there are otherfactors that may cause the study to be terminated midway, such as other seriousillnesses (including mental illnesses) that require concomitant treatment,serious laboratory abnormalities, accompanied by family or social factors,which may affect the safety of the subjects, or the collection of data andsamples.