Squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental Group:Perioperative treatment with Finotonlimab
Control group:Standard surgical treatment and postoperative adjuvant therapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the ICF. 2. Age>=18 years and =1.5×10?/L, platelets>=100×10?/L, hemoglobin>=90 g/L. b. Liver function: Serum total bilirubin =50%.
Exclusion criteria
Exclusion criteria: 1. Concurrent or previous history of other malignancies (except for cured basal cell carcinoma of the skin). 2. Known allergy to the active pharmaceutical ingredients or excipients of the investigational drug Feinoli Monoclonal Antibody, or presence of contraindications listed in the prescribing information. 3. Pregnant or lactating. 4. Congenital or acquired immunodeficiency. 5. Received systemic glucocorticoid therapy or other immunosuppressive therapy within 1 week prior to randomization. 6. Known history of allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation or bone marrow transplantation. 7. Presence of any active autoimmune disease or history of autoimmune disease. 8. Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases. 9. History of psychiatric disorders or substance abuse. 10. Participation in another anti-tumor drug clinical trial, or receipt of preventive vaccines or live attenuated vaccines, within 4 weeks prior to randomization. 11. Received prior radiotherapy to the head and neck region or systemic anti-tumor therapy before the start of the study. 12. Presence of Grade 3-4 bleeding risk due to malignancy. 13. Underwent major surgery prior to randomization or has not adequately recovered from the toxicity/complications of interventional treatment. 14. Radiologically visible central nervous system metastases (even if asymptomatic or treated) and/or carcinomatous meningitis. 15. History of non-infectious pneumonia requiring steroid treatment or current presence of pneumonia. 16. History of HIV infection, or active Hepatitis B (HBsAg positive), or active Hepatitis C (HCV RNA positive). 17. Any other condition deemed inappropriate for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year-EFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year-OS rate;reatment-related adverse events;Major Pathological Response Rate;Pathological complete response rate; | — |
Countries
China
Contacts
Public ContactHu Chaosu
Fudan University Shanghai Cancer Center
Outcome results
None listed