Head and neck squamous cell carcinoma
Conditions
Interventions
Experimental Group:Iparomlimab and Tuvonralimab Injection+Albumin-bound Paclitaxel + Cisplatin
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who were initially diagnosed with resectable stage III-IV (AJCC 8th edition) oral, oropharyngeal, laryngeal, or hypopharyngeal cancer, and pathologically confirmed as squamous cell carcinoma; Can provide tissue and blood samples for molecular marker detection; 2. At least one measurable solid tumor (response evaluation criteria: RECIST 1.1); 3. Age ranged from 18 to 75 years, ECoG score: 0-1; 4. Expected survival time >=3 months; 5. Patients who received no chemotherapy, radiotherapy, immunotherapy or biological therapy for the first time; 6. Vital organ function meets the following requirements (blood components, cell growth factors, white blood cell drugs, platelet drugs and anemia correction drugs are not allowed within 14 days before the first use of study drugs); (1)WBC>=3.0×10^9 /L; (2)ANC>=2.0×10^9/L, HB>=90g/L, platelet >=100x10^9 /L, serum albumin >=2.8g/dl, total bilirubin 60ml/min (Cockcroft Gault), activated partial thromboplastin time (APTT) and international normalized ratio (INR)<=1.5 ULN (for patients treated with stable doses of anticoagulation, such as low molecular weight heparin or warfarin, and for patients treated with a stable dose of anticoagulation, such as low molecular weight heparin or warfarin, The INR can be screened within the expected range of anticoagulant therapy). 7.There were no contraindications to chemotherapy and immunotherapy. 8. No history of immune-related diseases. 9. No uncontrolled pneumonia and pulmonary infection. 10. Participants of childbearing age must agree to use effective contraception during the trial; Women of reproductive age must have a negative serum or urine pregnancy test 72 hours before the start of chemotherapy. 11. The subjects had good compliance, were available for treatment and follow-up, and voluntarily complied with the provisions of this study. 12. All subjects voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastases. 2. Uncontrolled serious diseases, such as complex serious diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, peptic ulcer, etc. 3. Patients with a previous history of allergy or allergy to any component of the monoclonal antibody drug. 4. Uncontrolled cardiac clinical symptoms or diseases, such as heart failure NYHA class ? or above or left ventricular ejection fraction (LVEF) =470 MS); 5. Serious infection (CTC AE grade > 2) within 4 weeks before the first dose of study drug, such as severe pneumonia, bacteremia, and infectious complications requiring hospitalization; Active pulmonary inflammation on chest imaging at baseline, signs and symptoms of infection within 2 weeks before the first dose of the study drug, or the need for treatment with oral or intravenous antibiotics (excluding prophylactic antibiotics). 6. Fever of unknown origin > 38.5°C during screening and before the first dose (tumor-related fever was included in this group at the investigator's discretion); 7. Active autoimmune diseases and a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune hypothyroidism treated with stable doses of thyroid replacement hormone; Stable doses of insulin in patients with type 1 diabetes; Patients who have cured vitiligo or childhood asthma/allergies and do not require any intervention in adulthood; 8. A history of immunodeficiency, including testing positive for HIV, other acquired and congenital immunodeficiency disorders, or organ or allogeneic bone marrow transplantation. 9. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA > 500 IU/ml, or patients with active hepatitis C virus (HCV), should be excluded; Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA < 500iu/ml), and cured hepatitis C patients were eligible for this study. 10. A history of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) and noninfectious pneumonia. 11. Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but not receiving regular treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;R0 resection rate;Objective Response Rate (ORR);Event-free survival was 2 years;Overall survival was 2 years; | — |
Countries
China
Contacts
Public ContactCao Fangli
Qilu Hospital of Shandong University (Qingdao)
Outcome results
None listed