head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Tislelizumab combined with cisplatin and paclitaxel
Sponsors
Peking University Stomatological Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients signed a written informed consent before enrolling in the study, and must be willing and able to comply with the visits, treatment plans, laboratory tests and other requirements in the study plan; 2. The criteria for surgical resection should meet the following three points at the same time: no invasion of important structures, including internal carotid artery, common carotid artery, skull base bone, cervical spine, pleura, and mediastinum; no subcutaneous metastases; the body can tolerate general anesthesia surgery; 3. Histologically confirmed stage III/IV head and neck squamous cell carcinoma recurrence after radiotherapy, the rTNM staging of recurrent head and neck squamous cell carcinoma should meet T3-4 or N1-3, and there is no distant metastasis (M0); 4. Patients with ECOG physical status score of 0-2; 5. The patient's age is greater than or equal to 18 years old; 6. There are measurable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 7. Tumor tissue (archived or fresh biopsy specimens) must be available for PD-L1 expression analysis and other biomarkers (TMB, microsatellite stability) detection; PD-L1 detection uses PD-L1 detection kit PD-L1 IHC (immunohistochemistry, Dako 28-8 or 22C3) to supplement the diagnosis; If this method has been used to detect PD-L1 status before, there is no need to perform the test again, but the testing unit must be the laboratory department of the top three hospitals in Beijing; PD-L1 status can be expressed using TPS or CPS, regardless of PD-L1 status; 8. Previous curative radiation (curative radiation) must be completed at least 4 weeks before study administration; 9. Biochemical (obtained within 14 days prior to study entry, with test values within the ranges specified below): (1) Leukocytes >= 2000/µL (2.0x10^9/L); (2) Neutrophil >= 1500/µL (1.5x10^9/L); (3) Platelets >= 100x10^3/µL (100x10^9/L); (4) Hemoglobin >= 9.0 g/dL (90 g/L) or >= 5.6 mmol/L; (5) Serum creatinine 1.5xULN or creatinine clearance (CrCl) > 40 mL/min (using the Cockcroft-Gault formula): Female CrCl=(140-age) x body weight (kg) x 0.85 / (72xScr mg/dl); Male CrCl=(140-age) x body weight (kg) x 1.00 / (72xScr mg/dl); (6) AST/ALT= 92%; 10. Females of childbearing age must agree to contraception during study drug treatment (5 half-lives of study drug) plus 30 days (duration of the ovulatory cycle, 23 weeks after the end of treatment). Males of childbearing age must agree to contraception during study drug use, plus 5 half-lives and 90 days (sperm turnover time) of study drug use, for a total of 31 weeks of contraception after completion of treatment.
Exclusion criteria
Exclusion criteria: 1. History of autoimmune diseases, including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis (Note: Vitiligo, type 1 diabetes, residual hypothyroidism due to autoimmune disease (eg, after Hashimoto's syndrome) require only hormone replacement therapy, psoriasis does not require systemic therapy, patients or patients who were not expected to relapse in the absence of external triggers were allowed to enroll. ); 2. Patients with active brain or meningeal metastasis; 3. Patients with squamous cell carcinoma of unknown primary focus; 4. Patients with uncontrolled malignant tumors in the past 3 years; 5. Patients with a history of primary immunodeficiency or a history of allogeneic organ transplantation; 6. Anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTL A-4 antibody, or any other antibody or drug targeting T cell costimulation or immune checkpoint pathway before treatment; 7. Administered live attenuated vaccine within 30 days; 8. Suffering from untreated and/or uncontrolled cardiovascular disease, and/or symptomatic cardiac dysfunction (Unstable angina, congestive heart failure, myocardial infarction within the past year or ventricular arrhythmia requiring medical therapy, history of 2nd or 3rd degree atrioventricular block). Patients with a history of major cardiac disease, even if controlled, must have an LVEF >50% within 12 weeks prior to immunotherapy; 9. Patients with severe (total bilirubin > 3 times ULN and any AST) liver injury; 10. Patients with interstitial lung disease; 11. Pregnant or lactating patients; 12. All toxicities related to previous anticancer therapy must reach grade 1 (NCI CTCAE v4) or baseline level before administration; patients who have received anticancer treatment, whose toxicity is not expected to subside and lead to long-term sequelae, such as neuropathy after platinum drug treatment, are allowed to be enrolled; 13. Physical and laboratory test results: (1) Hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) positive, indicating acute or chronic infection; (2) Known positive test history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); (3) Any grade 4 laboratory abnormalities; 14. Allergies and adverse drug reactions: history of allergy to drug components; history of severe allergic reactions to any monoclonal antibody; 15. Active serious clinical infection, including active tuberculosis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological remission; | — |
Countries
China
Contacts
Public ContactZhang Jie
Peking University Stomatological Hospital
Outcome results
None listed