A Phase II Trial of Camrelizumab in Combination With Apatinib for Neoadjuvant Treatment of Early-stage TNBC With a High Proportion of TILs

Exclusion Criteria

• •1. Combination of other malignancies or previous malignancies other than breast cancer within the last 5 years, except for basal cell carcinoma or flat cell carcinoma of the skin or carcinoma in situ of the uterine cervix that has been adequately controlled by treatment.
• •2. Those who are not suitable for immunotherapy in combination with active infection.
• •3. The combination of severe non-malignant disease that would affect patient compliance or put the patient at risk.
• •4. Concomitant with other antineoplastic therapy or are participating in other clinical trials.
• •5. Male breast cancer, bilateral breast cancer or inflammatory breast cancer.
• •6. Patients with dementia, mental abnormality or any mental illness that prevents understanding of the informed consent form.
• •7. Patients with history of allergic reaction or contraindication to the use of any drug component of this trial.
• •8. Patients with any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose asthma has completely resolved in childhood and does not require any intervention in adulthood may be included; (Patients with asthma that requires medical intervention with bronchodilators cannot be included).
• •9. Have cardiac clinical symptoms or disease that are not well controlled, such as:
• •(1) NYHA class 2 or higher heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• •10\. Urine routine suggestive of urine protein ≥++, or confirmed 24-hour urine protein amount ≥1.0g.
• •11\. Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hypersplenism, etc.).
• •12\. Patients with congenital or acquired immune deficiencies (e.g., HIV-infected individuals).
• •13\. Live vaccines administered less than 4 weeks prior to study drug administration or possibly during the study.
• •14\. Active tuberculosis. 15. Patients have received oral or intravenous antibiotic therapy within 2 weeks prior to neoadjuvant therapy.
• •16\. Major surgical procedure within 4 weeks prior to the start of study treatment or anticipated need for major surgical procedure during the course of the study.