Head and neck squamous cell carcinoma
Conditions
Interventions
experimental group:Sequentially administer 3 cycles of single agent of ?Iparomlimab and Tuvonralimab (5mg/kg, D1, Q3W) after LDRT and SBRT
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old; 2. Expected survival >= 3 months; 3. According to the 9th edition of the UICC/AJCC TNM staging system, patients with locally advanced head and neck squamous cell carcinoma (including oropharyngeal cancer, laryngeal cancer, and hypophthalmic cancer) are classified as stage III-IVA; 4. Researchers determine that the subjects are eligible for surgery; 5. ECOG PS is 0-1 points; 6. Based on RECIST 1.1 criteria, there must be at least one assessable lesion; 7. Possess sufficient organ function, specifically meeting the following standards: Hemoglobin >= 90g/L Absolute neutrophil count >= 1.5 × 10^9/L Platelet count >= 100 × 10^9/L Serum total bilirubin (TBIL) = 50mL/min, calculated using the Cockcroft Gault formula (based on actual body weight) or measured through 24-hour urine collection. Female: creatinine CL=body weight (kg) × (140 age) × 0.85 (mL/min) 72 × serum creatinine (mg/dL) -Activated partial thromboplastin time (APTT) and prothrombin time (PT) <= 1.5 x upper limit of normal (ULN), international normalized ratio (INR) <= 1.5 x upper limit of normal (ULN) 8. Within 14 days prior to the examination, no blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor therapy has been received; 9. Voluntarily sign and participate in this study and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Active or known or suspected autoimmune diseases requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, and asthma requiring intervention with bronchodilators. 2. HIV infection, active hepatitis B or hepatitis C infection. 3. Merge with other primary malignant tumors. 4. Pregnant or lactating female patients. 5. There are other serious comorbidities, including NYHA III-IV heart failure, CNS disease, hematological disorders, liver and kidney malformations, or a history of surgery. 6. Previously treated with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody. 7. Unable or unwilling to sign an informed consent form. 8. Researchers believe that other situations are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathologic Response (MPR);R0 Resection Rate;Objective Response Rate (ORR);Event-Free Survival (EFS); | — |
Countries
China
Contacts
Public ContactRui Liu
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed