Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment

Exclusion Criteria

• •1. Patients with a history of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA \<2000 IU), or HIV infection.
• •2. Patients expected to be unable to tolerate surgery, such as those with severe cardiopulmonary insufficiency or coagulation disorders (APTT \<1.5 times ULN, INR \>2.0, PT \>16 seconds).
• •3. History of other malignancies within the past 2 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, superficial bladder cancer \[Ta, Tis \& T1\], or papillary thyroid carcinoma.
• •4. Any unstable systemic disease (including active systemic infections requiring systemic treatment, liver disease, kidney disease, or metabolic disorders, acute cerebral infarction or cerebral hemorrhage, etc.).
• •5. Significant cardiovascular events: congestive heart failure \> NYHA Class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction over 1 year before study entry is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension.
• •6. Significant neurological or psychiatric disorders, including epilepsy, dementia, etc.
• •7. Patients with interstitial lung disease or a history of interstitial pneumonia.
• •8. Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment.
• •9. Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs.
• •10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation.
• •11. Known allergy to the drugs or drug excipients used in the study or severe allergic reactions to other monoclonal antibodies.
• •12. Presence of other severe physical or laboratory abnormalities that may increase the risk of participating in the study, interfere with study results, or any other condition that, in the investigator's judgment, may affect the conduct or results of the clinical study.