Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma

Inclusion Criteria:

1. Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathologicalexamination

2. PET-CT confirmed no metastasis;

3. ECOG physical status score 0-1;

4. Bronchoscopy, and chest CT is evaluated as early or locally advanced trachealmalignant tumor, and radical surgery is expected to be feasible or after neoadjuvanttherapy.

5. Age ≥ 18 years;

6. Have one measurable lesion at least;

7. Good function of other major organs (liver, kidney, blood system, etc.):-absoluteneutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L).Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-Internationalstandardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum totalbilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST andALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN

8. Fertile female patients must voluntarily take effective contraceptive measures morethan 120 days after chemotherapy or the last administration of Nivolumab, whicheveris later, and the urine or serum pregnancy test results less than 7 days beforeentering the group were negative. Unsterilized male patients must voluntarily takeeffective contraceptive measures ≥ 120 days after chemotherapy or the lastadministration of Nivolumab, whichever is the latter.

9. Sign informed consent;

Exclusion Criteria:

1. Any Chinese herbal medicine used to control cancer was used within 14 days beforethe first administration of the study drug;

2. Patients with other malignant tumors in the five years before the start of thistrial.

3. Complicated with unstable systemic diseases, including active infections,uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidneyor metabolic diseases;

4. Active, known or suspected autoimmune diseases, or autoimmune paraneoplasticsyndrome requiring systemic treatment;

5. A history of active bleeding or embolism within 6 months, or received thrombolysisor anticoagulation therapy, or the researchers believe that there is an obvioustendency of gastrointestinal bleeding (such as esophageal varices have the risk ofbleeding, local active ulcer lesions, etc.);

6. Had is suffering from nephrotic syndrome

7. Allergic to experimental drugs;

8. Complicated with HIV infection or active hepatitis.

9. Vaccination within 4 weeks before the start of this trial;

10. Those who had undergone other major operations or severe injuries within theprevious 2 months;

11. Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominalpuncture drainage within 2 weeks before admission;

12. Pregnant or lactating women;

13. Those with neurological diseases or mental disorders.

14. Participated in another therapeutic clinical study at the same time;

15. Other researchers did not consider it appropriate to enroll in the group.