Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Patientsreceived tislelizumab chemotherapy for 2-3 cycles for neoadjuvant treatment . Patients who achieved MPR after surgery received tislelizumab
patients who did not achieve MPR received standard adjuvant radiotherapy combined with nimotuzumab, followed by tislelizumab.
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Patients with head and neck malignancies diagnosed with squamous cell carcinoma by pathology; 3. Initially resectable stage III-IVb oral cancer/hypopharyngeal cancer/laryngeal cancer/p16- oropharyngeal cancer, or stage II-III p16+ oropharyngeal cancer (AJCC 8th), and planned to undergo surgical resection; 4. Planned neoadjuvant therapy; 5. No previous anti-tumor treatment for HNSCC; 6. Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-1; 7. Expected survival >= 3 months 8. The function of important organs meets the following requirements (excluding the use of any blood components and cell growth factors within 7 days): Normal bone marrow reserve function, white blood cells (WBC)>= 3.0×10^9/L; neutrophil count (NEUT) >=1.5×10^9/L, platelet count (PLT) >=100×10^9/L, hemoglobin (Hb) >=90 g/L; Normal renal function or serum creatinine (SCr) =50 ml/min (Cockcroft-Gault formula); Normal liver function or total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level <= 2.5 times the upper limit of normal (ULN); 9. Able and willing to comply with the study and follow-up procedures; 10. Males and females of childbearing age must agree to take adequate contraceptive measures throughout the study and within 6 months after the end of treatment; 11. Patients voluntarily join this clinical study and sign the informed consent form, with good compliance and able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) in the past; 2. Patients with primary lesion stage T4b; 3. Patients with a clear history of allergies and potential allergies or intolerance to the study drug and its similar biological agents; 4. Patients who have participated in other anti-tumor drug clinical trials within 4 weeks before the first dose; or patients who have received attenuated live vaccines within 4 weeks before the first dose or planned to receive them during the study; 5. Patients who have developed other malignancies within 5 years (except for adequately treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin); 6. Patients who have used immunosuppressive drugs within 14 days before the first use of tislelizumab, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg/day of prednisolone or other corticosteroids of equivalent physiological doses) 7. Advanced patients with symptoms, dissemination to internal organs, and risk of life-threatening complications in the short term (including patients with uncontrolled large amounts of exudate [thoracic, pericardial, abdominal], pulmonary lymphangitis, and more than 30% liver involvement) 8. Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete asthma relief in childhood and no need for any intervention as adults can be included; subjects with asthma that requires medical intervention with bronchodilators cannot be included) 9. ??Patients with grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval =450ms for men and =470ms for women). According to NYHA standards, patients with grade III-IV heart failure, or left ventricular ejection fraction (LVEF) 38.5°C during the screening period/before the first medication; 11. Patients with a history of psychotropic drug abuse and unable to quit or with mental disorders; 12. Patients with major surgical operations within 4 weeks before the first medication. or with open wounds or fractures; 13. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; 14. Central nervous system metastasis; 15. Patients with a history of hereditary or acquired bleeding or coagulation disorders (the specific selection is determined by the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2y-EFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;pCR rate; | — |
Countries
China
Contacts
Public ContactYan Wang
The First Affiliated Hospital of China Medical University
Outcome results
None listed