head and neck squamous cell carcinoma
Conditions
Interventions
Head and neck group:After 3 cycles of adebrelimab combined with TP induction chemotherapy, adebrelimab combined with concurrent chemoradiotherapy was given, and adebrelimab was given within 4 to 6 wee
Nasopharyngeal group:After 3 cycles of adebrelimab combined with GP induction chemotherapy, adebrelimab combined with concurrent chemoradiotherapy was given, and adebrelimab was given within 4 to 6 we
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Head and neck squamous cell carcinoma of the oral cavity, oropharynx (p16-), hypopharynx, or larynx with histologically or cytologically confirmed nasopharyngeal carcinoma, WHO type II or III; 2. Inoperable stage III-IVa locally advanced head and neck squamous cell carcinoma diagnosed according to the AJCC 8th edition staging system, of which the exploratory group was stage III-Iva nasopharyngeal carcinoma, excluding T3N0 patients; 3. Have not received other systemic antitumor therapy or local radical therapy for LA-HNSCC; 4. CPS>=1 (except exploratory group); 5. Clinically evaluable lesions according to RECIST1.1 (lesion long diameter >=10 mm or lymph node short diameter >=15 mm); 6. The age of signing the informed consent form was 18-70 years old, male or female; 7. ECOG PS 0-1; 8. Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : Normal bone marrow reserve: white blood cell (WBC) >=3.0×10^9/L, neutrophil count (NEUT) >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L, hemoglobin (Hb) >=90 g/L Normal renal function or serum creatinine (SCr) =50 ml/ minute (Cockcroft-Gault equation) 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. Be able and willing to follow the study and follow-up procedures; 10. Men and women of childbearing potential must agree to use adequate contraception throughout the study and for 6 months after the end of treatment. Female subjects of childbearing potential must have a negative blood pregnancy test within 72 hours before the first dose; 11. The subjects voluntarily participated in this clinical study, and signed the informed consent form, with good compliance and good cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Received any previous systemic antitumor therapy against the target lesion; 2. Prior radiation therapy to the head and neck; 3. Patients who had received any previous immunotherapy such as anti-PD-1 /PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody; 4. Subjects who received anti-tumor vaccine or other immunomodulatory drugs (such as interleukin-2, thymosin, lentinan, etc.) within 1 month before enrollment, or who will be vaccinated with live attenuated vaccine; 5. Participants who had received systemic treatment with corticosteroids (>10 mg/ day of prednisone or equivalent) or other immunosuppressive agents within 1 month before enrollment. Inhaled or topical corticosteroids and glucocorticoid-replacement therapy at a therapeutic dose of prednisone of 10 mg or less per day were allowed in the absence of active autoimmune disease. 6. Patients with clinical symptoms of pleural effusion, pericardial effusion, or ascites requiring drainage, or treated with drainage of serous cavity effusion for treatment within 2 weeks before enrollment; 7. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism) were excluded; 8. Subjects who had a serious infection within 1 month before enrollment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection, or unexplained fever >38.5 ° C during screening or before the first dose; 9. Severe cardiovascular disease: grade ? or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmia (QTc interval >= 450 ms in men and >= 470 ms in women); Patients with grade ?-? cardiac dysfunction (according to the New York Heart Association NYHA classification, see Appendix 3) or left ventricular ejection fraction (LVEF) less than 50% on echocardiography; 10. Subjects with systemic treatment such as bronchodilators and unsatisfactory asthma control could not be included (patients with complete remission of asthma in childhood and without any intervention in adulthood could be included); 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA>=500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method) or co-infection with hepatitis B and C; 12. Subjects with a history of other malignancies within 5 years (except for cervical cancer in situ or complete treatment of basal cell or squamous cell carcinoma skin cancer); 13. Patients with a clear history of allergy may be potentially allergic or intolerant to camrelizumab; 14. Have a history of psychotropic drug abuse and cannot quit or have mental disorder; 15. Other conditions that increase the risk associated with participating in the study or the study drug and, in the investigator's judgment, would make the subject ineligible for the study; 16. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;2 Year-Overall Survival Rate;2 Year-Event-free Survival Rate;Safty; | — |
Countries
China
Contacts
Public ContactXia He
Jiangsu Cancer Hospital
Outcome results
None listed