A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC

Exclusion Criteria

• •1. Received other interventional clinical trials within 28 days before the first dose;
• •2. Failure to recover from adverse reactions of previous treatment
• •3. Neurological disorders of grade ≥ 2
• •4. Untreated active brain metastases or meningeal metastases
• •5. Previously received nab-paclitaxel neoadjuvant therapy or adjuvant therapy and experienced local recurrence or distant metastasis within 12 months;
• •6. Has experienced severe allergic reactions to other monoclonal antibodies;
• •7. Received other anti-tumor treatments within 28 days before the first administration;
• •8. Suffering from hypertension and unable to achieve good control with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
• •9. Received antibody or T cell co stimulatory therapy such as PD-1, PD-L1, PD-L2, CTLA-4, Tim3, LAG3, etc;
• •10. Special genetic diseases (including rare galactose intolerance, primary lactase deficiency, or glucose galactose malabsorption);
• •11. Active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma without any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators may not be included);
• •12. Heart diseases, such as:
• •* NYHA grade 2 or above heart failure
• •* Unstable angina pectoris
• •* Have experienced a myocardial infarction within the past year
• •* Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention；
• •13. Urine protein level is ≥++, or the 24-hour urine protein level is ≥ 1.0 g;
• •14. Known genetic or acquired bleeding and thrombophilia tendencies (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.);
• •15. Have a history of tuberculosis;
• •16. Active period of HBV or HCV, and other active infectious diseases;
• •17. Had or is currently experiencing qualitative pneumonia or requires steroid treatment for pneumonia;
• •18. Congenital or acquired immune dysfunction (such as HIV infected individuals);
• •19. Received or about to receive a live vaccine within 4 weeks prior to the study or possibly during the study period;
• •20. Allergic or contraindicated to the experimental drug.