squamous cell carcinoma of the head and neck
Conditions
Interventions
test group:Neoadjuvant Envafolimab plus Chemotherapy
Sponsors
Peking University Hospital of Stomatology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with head and neck squamous cell carcinoma through histopathological or cytological examination; According to the AJCC Tumor Staging Manual (8th edition), patients diagnosed with stage III or IV squamous cell carcinoma of the head and neck without distant metastasis, including squamous cell carcinoma in the oral, oropharyngeal, pharyngeal, and laryngeal regions; Planned surgical resection or potential surgical feasibility; 2. Plan to undergo neoadjuvant therapy; 3. Have not received any anti-tumor treatment for head and neck squamous cell carcinoma in the past, including but not limited to surgical treatment, radiation therapy, drug therapy, and biological therapy; 4. Before treatment, according to RECIST 1.1, there should be clinically assessable lesions; 5. Age = 18 years old and gender not limited when signing the informed consent form; 6. ECOG (Eastern Cooperative Oncology Group) score is 0-1; 7. 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 cell (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); AST or ALT levels <= 2.5 times the upper limit of normal (ULN); 8. Able and willing to comply with research and follow-up procedures; 9. Pregnant men and women must agree to take adequate contraceptive measures throughout the entire study period and within 6 months after the end of treatment; 10. The patient voluntarily joined this clinical study and signed an informed consent form, with good compliance and the ability to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received anti-PD-1 antibody, anti-PD-L1 antibody, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation or checkpoint pathway); 2. Have a history of known allergies, and may be potentially allergic or intolerant to the study drug and any other biological agents; 3. Participated in other anti-cancer drug clinical trials within 4 weeks prior to the first dose; or planned to receive a live attenuated vaccine within 4 weeks prior to the first dose or during the study; 4. Had any other malignancy within 5 years (excluding basal cell carcinoma of the skin that has been fully treated or is under control); 5. Used immunosuppressive medications within 14 days prior to the first dose of envorlimab, excluding intranasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., no more than 10 mg of prednisone or equivalent daily doses of other corticosteroids); 6. Have symptomatic, metastatic disease that has spread to internal organs, with a high risk of life-threatening complications in the short term (including patients with uncontrolled massive effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and more than 30% liver involvement); 7. Have any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or childhood asthma that has been fully resolved in adulthood without any intervention may be included; patients with asthma requiring medical intervention with bronchodilators cannot be included); 8. Patients with grade II or higher myocardial ischemia or infarction, uncontrolled arrhythmia (including QTc interval male >=450ms, female >=470ms), NYHA standard III-IV heart failure, or echocardiography showing left ventricular ejection fraction (LVEF) 38.5°C during the screening period/before the first dose; 10. Patients with a history of substance abuse with no evidence of abstinence or patients with a history of mental illness; 11. Patients who have undergone major surgery within 4 weeks prior to the first dose or have open wounds or fractures; 12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >=500 IU/ml), hepatitis C (anti-HCV positive and HCV-RNA above the detection limit), or co-infection of hepatitis B and C; 13. Central nervous system metastasis; 14. Patients with a history of inherited or acquired bleeding disorders or coagulation disorders (determined by the investigator to be eligible); 15. Other situations determined by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response, pCR;objective response rate;Event free survival;Overall survival;safety and tolerability;Pain rating and quality of life; | — |
Countries
China
Contacts
Public ContactJie Zhang
Peking University Hospital of Stomatology
Outcome results
None listed