Toripalimab Combined With Gemcitabine and Cisplatin Treating Resectable Locally Advanced HNSCC

Exclusion Criteria

• •1. Pregnant or lactating women;
• •2. Allergic to anti-PD-1 monoclonal antibody, gemcitabine, or cisplatin;
• •3. History of other malignant tumors in the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma;
• •4. Uncontrollable clinical symptoms or diseases of the heart, such as: (1) Heart failure, NYHA Ⅱ, III or IV (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Supraventricular in clinical significance or Patients with ventricular arrhythmia requiring clinical intervention;
• •5. Have received any of the following treatments:
• •1. Have received any research relevant drugs before enrolling in this research;
• •2. Enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or intervention in a new clinical study follow-up;
• •3. Patients who need to be given corticosteroids (more than 10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before giving medication for the first time, except for local inflammation and prevention of allergies, nausea and vomiting The case of corticosteroids. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal corticosteroids with a dose greater than 10 mg per day of prednisone curative dose are allowed to replace;
• •4. Have been vaccinated with anti-tumor vaccine or have been vaccinated with live vaccine within 4 weeks before the first administration of study drug;
• •5. Received major surgery or severe trauma within 4 weeks before using the study drug for the first time;
• •6. The left ventricular ejection fraction of the heart is greater than or equal to 60%;
• •6. Severe infection (CTC AE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest active lung inflammation , There are symptoms and signs of infection 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment (excluding prophylactic use of antibiotics);
• •7. Have active autoimmune diseases, history of autoimmune diseases;
• •8. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation;
• •9. Patients with active tuberculosis infection found through medical history or CT examination, or patients with a history of active tuberculosis infection within 1 year before enrollment, or patients with a history of active tuberculosis infection but without formal treatment 1 year before being checked;
• •10. The subject has active hepatitis (HBV DNA ≥ 2000IU/ml or 10,000 copies/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the lower limit of the analysis method);
• •11. History of psychotropic drug abuse, alcohol and drug abuse;
• •12. Symptomatic brain metastases (confirmed or suspected);
• •13. The patients who are reckoned as not suitable for inclusion.