Locally advanced head and neck squamous cell carcinoma
Conditions
Interventions
Low dose radiotherapy combined with immunotherapy group:Low dose radiotherapy combined with pembrolizumab and TP regimen chemotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up; 2. Age 18-75 years old, including 18 and 75 years old, male or female; 3. Squamous cell carcinoma of the head and neck confirmed by histopathology; 4. ECOG: 0~1 point; 5. Refer to the 8th edition of AJCC staging for staging. The clinical stage was stage III~IV, and there were no patients with distant metastases; 6. The function of vital organs meets the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of the screening examination): a. Absolute neutrophil count (ANC) >=1.5×10^9/L; b. Platelet >=100×10^9/L; c. Hemoglobin >=9g/dL; d. Serum albumin >=2.8g/dL; Total bilirubin =60mL/min (calculated according to the Cockcroft-Gault formula); g. International normalized ratio (INR) and activated partial thromboplastin time (APTT) <=1.5× ULN (for anticoagulant therapy at stable doses, such as low molecular weight heparin or warfarin, and INR is within the expected therapeutic range of anticoagulants, it can be screened); 7. Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug and be certified negative, and willing to use an effective method of contraception during the trial period and for 6 months after the last dose. For male participants whose partner is a woman of childbearing age, an effective method of contraception should be used during the trial and for 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Previous PD-1/PD-L1/CTLA-4 antibody therapy; 2. Previous head and neck radiotherapy; 3. Patients who require systemic glucocorticoids (> 10 mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to dosing or during treatment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroids at doses > 10mg/day prednisone equivalent doses are allowed, and adrenocorticosteroid replacement therapy with efficacy doses not exceeding 10mg/day of prednisone is allowed; 4. Presence of any history of active immune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 5. Active or uncontrolled severe infection (>=NCI CTCAE v5.0 grade 2 infection) within 4 weeks prior to enrollment; 6. Coagulation abnormalities (INR>1.5 or prothrombin time (PT) >ULN 4 seconds or APTT >1.5 ULN), bleeding tendency, or being treated with thrombolysis or anticoagulation; Note: Under the premise of the international normalized ratio (INR) of prothrombin time =CTCAE grade 2 with unhealed wounds, ulcers, or fractures in the 4 weeks prior to grouping 9. Abnormal function of major organs: (1) Abnormal routine blood examination (transfusion of blood and blood products within 14 days, correction with G-CSF and other hematopoietic stimulating factors): a) Hemoglobin (HB) 1.5* upper limit of normal (ULN); b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5×ULN; c) Serum creatinine (Cr) >1.5×ULN or creatinine clearance (CCr) upper limit of normal (ULN) and abnormal T3 and T4 levels; 10. Renal insufficiency: urine routine shows that urine protein > = , or confirmed 24-hour urine protein volume > = 1.0g; 11. Grade I myocardial ischemia or myocardial infarction, arrhythmia (including QTc >=480ms) and >=grade 2 congestive heart failure (New York Heart Association (NYHA) classification) within 6 months prior to enrollment; 12. Diagnosed with other malignant tumors within 3 years prior to enrollment; 13. Patients with any severe and/or uncontrolled disease, including: a) Patients with unsatisfactory blood pressure control (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg); Patients with grade I myocardial ischemia or myocardial infarction, arrhythmias (including QT interval >=430 ms) and grade I cardiac insufficiency (New York Heart Association (NYHA) cardiac function class); b) Active or uncontrolled severe infection; c) Such as cirrhosis, decompensated liver disease, active hepatitis HBV or HCV; d) poorly controlled diabetes mellitus (fasting blood glucose (FB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Organ retention rate;Objective remission rate;Major Pathological Response, MPR;R0 removal rate;Disease Free Survival, DFS;Local Recurrence-Free Survival, LRFS;Distant Metastasis-Free Survival, DMFS;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactLiu Juying
Jiangsu Cancer Hospital
Outcome results
None listed