Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental group:Enrolled by immune superadvanced genetic testing. Subjects without immune hyperprogressive genes enter Cohort A and will receive 2-4 cycles of neoadjuvant therapy with cetuximab ß,
Patients received a total of 6 cycles of perioperative medical treatment before and after surgery. Subjects with immune hyperprogressive genes entering Cohort B will receive 2-4 cycles of neoadjuvant
Patients received a total of 6 cycles of perioperative medical treatment before and after surgery
Sponsors
The First People's Hospital of Lianyungang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with head and neck squamous cell carcinoma by histopathological or cytological examination (except nasopharyngeal carcinoma); Clinical stage T1, N2-3; T2, N1-3, T3/T4a, any N (AJCC, 8th edition), based on PET/CT or CT, no evidence of distant metastases (M0) in the abdomen and pelvis, standard of care treatment requiring surgical resection adjuvant radiotherapy /chemotherapy; Able to provide tissue and hematology specimens for molecular marker testing; 2. Planned neoadjuvant therapy and surgical resection; 3. No previous anti-tumor treatment for head and neck squamous cell carcinoma, including but not limited to surgical treatment, radiation therapy, drug therapy and biological therapy; 4. Clinically evaluable lesions according to RECIST1.1 before treatment; 5. Age >=18 years old at the time of signing the informed consent form, gender is not limited; 6. ECOG (Eastern Cooperative Oncology Group) score of 0-1; 7. The function of vital 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); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels <= 2.5 times the upper limit of normal (ULN); 8. Men and women of gestational age must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment; 9. Patients voluntarily join this clinical study, sign the informed consent form, have good compliance, and can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous radiotherapy, systemic therapy, anti-PD-1 antibody, anti-PD-L1 antibody, or anti-CTLA-4 antibody (or any other antibody acting on T-cell synergistic stimulation or checkpoint pathway) for head and neck cancer. 2. Active or prior documented autoimmune or inflammatory disease with prior steroid or immunomodulatory therapy within the past 5 years. 3. Has a clear history of allergy, and may have a potential allergy or intolerance to the study drug and its similar biological agents; 4. Participated in other anti-tumor drug clinical trials within 4 weeks before the first dose; or within 4 weeks prior to the first dose or planned receipt of a live attenuated vaccine during the study; Other malignancies within 5.5 years (except adequately treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin); 6. Advanced patients with symptoms, disseminated to internal organs, and at risk of life-threatening complications in the short term (including patients with uncontrollable massive exudate [chest, pericardium, abdominal cavity], pulmonary lymphangitis, and more than 30% liver involvement); 7. Presence of 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 asthma in childhood who have been completely relieved and do not need any intervention in adulthood can be included; Asthma requiring bronchodilators for medical intervention cannot be included). 8. Use of immunosuppressive drugs within 14 days prior to the first use of camrelizumab, 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 at equivalent physiological doses of the drug); 9. Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval male >=450ms, female >=470ms). According to NYHA standards, grade III.~IV. cardiac insufficiency, or cardiac color ultrasound examination shows that the left ventricular ejection fraction (LVEF) is during screening/before the first dose 38.5°C; 11. Those who have a history of psychotropic substance abuse and cannot abstain from abstinence, or have mental disorders; 12. Major surgical procedures or open wounds or fractures within 4 weeks before the first dose; 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 lower limit of detection of the analytical method), or combined with hepatitis B and hepatitis C co-infection; 14. Those with a history of hereditary or acquired bleeding or coagulation dysfunction (as judged by the investigator); 15. Other conditions judged by the investigator to be unsuitable f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Event-free survival ;Overall survival ;Safety; | — |
Countries
China
Contacts
Public ContactZiyu Jiang
The First People's Hospital of Lianyungang
Outcome results
None listed