Squamous cell carcinoma of the head and neck
Conditions
Interventions
experimental group:Finolizumab combined with low-dose radiotherapy and neoadjuvant therapy
control group:Filanlimab combined with neoadjuvant therapy
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood this study and voluntarily signed the informed consent form, complying with the requirements of this study and the evaluation schedule; 2. No gender restriction, aged >=18 and =1.5×10^9/L; b) Platelets >=75×10^9/L; c) Hemoglobin >=90g/L (2) Hepatic and renal function: (no albumin transfusion within 14 days before screening): a) serum creatinine 50 mL/min; b) total serum bilirubin <=1.5×ULN; c) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5×ULN (3) Coagulation function: a) International normalized ratio (INR) <=2.3 or prothrombin time (PT) exceeding the normal control range by <=6 seconds;
Exclusion criteria
Exclusion criteria: 1. Currently or previously suffering from other active malignant tumors except for squamous cell carcinoma of the head and neck; 2. Currently or previously receiving immunotherapy and targeted therapy; 3. Have undergone major surgery within 4 weeks prior to the commencement of the study treatment; 4. Patients with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 5. Individuals who are allergic to any of the components of the study medication; 6. Have received antibiotic treatment within 2 months prior to the commencement of the study treatment; 7. Expected survival duration < 3 months; 8. Currently or previously suffering from moderate or severe liver or kidney damage; 9. Patients who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation; 10. Patients with congenital or acquired immune deficiency (such as HIV-infected individuals); 11. Having significant cardiovascular diseases, including unstable angina pectoris or myocardial infarction, within 6 months prior to the commencement of the study treatment; 12. Suffering from heart failure of NYHA class III/IV; 13. For those with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders, the investigator shall assess whether their clinical severity hinders the signing of the informed consent form or affects the patient's compliance with oral medications; 14. According to the researcher's judgment, the patient has other factors that may affect the study results or lead to the forced termination of this study midway, such as alcohol abuse, drug abuse, other serious diseases (including mental illnesses) requiring combined treatment, severe laboratory test abnormalities, and accompanying family or social factors that may affect the patient's safety; 15. Pregnant or lactating women; 16. Situations where other researchers assessed as unsuitable for inclusion in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life,QOL;Major Pathological Responce,MPR;Adverse reactions of immune checkpoint inhibitors;No surgery delay rate;Adverse reactions of radiotherapy;R0 resection rate;Adverse reactions of chemotherapy drugs;Reduce the scope of surgery/decrease the proportion of patients requiring skin flaps;Objective Response Rate,ORR; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Hospital of China Medical University
Outcome results
None listed