Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Experimental Group:Docetaxel + cisplatin + ivocizumab
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent before screening; 2.Age 18-65 years old; 3.ECOG performance status score 0-1; 4. Histologically or pathologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses);HPV status for oral and oropharyngeal tumors must be known; 5.The initial treatment stage is locally advanced (stage III-IVB, AJCC 8th edition) and cannot be radically resected after surgical evaluation; 6.According to the solid tumor response evaluation criteria (RECIST version 1.1), there are evaluable lesions; 7.Adequate organ function, defined as the following laboratory test results = 1.5×10^9/L, platelets >= 100×10^9/L, hemoglobin >= 90g/L;(2)Renal function requirements within 4 weeks before treatment: endogenous creatinine clearance >= 60mL/min. (calculated based on 24-hour urine creatinine or Cockcroft-Gault formula);(3)Serum total bilirubin = 60 days after the last study treatment (including chemotherapy), and have a negative urine or serum pregnancy test result 45 years with 12 months of amenorrhea without other biological or physiological reasons;in addition, to confirm menopause, women under the age of 55 must have a serum follicle-stimulating hormone (FSH) level of > 40mIU/mL; 10.Male subjects who are not sterilized must be willing to take highly effective contraceptive measures during the study and for >= 60 days after the last study treatment (including chemotherapy).
Exclusion criteria
Exclusion criteria: 1.Patients who have received any treatment for tumors in the past; 2. Patients who have received treatment targeting PD-1, PD-L1, PD-L2, CTLA4 and VEGF; 3.Oral or oropharyngeal squamous cell carcinoma diagnosed as HPV positive by pathology; 4.Patients with evidence of fistula (esophagus/bronchus or esophagus/aorta); 5. Patients with active autoimmune diseases or a history of autoimmune diseases but with possible recurrence (patients with the following diseases are not excluded and can enter further screening: (1) Controllable type 1 diabetes;(2) Hypothyroidism (if it can be controlled with hormone replacement therapy alone);(3) Controllable celiac disease; (4) Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia);(5) Any other diseases that are not expected to recur if there are no external triggers); 6. = grade 2 within 6 months before treatment; (6) cerebrovascular accident within 6 months before treatment; (7) uncontrolled hypertension: systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg despite the use of antihypertensive drugs within 28 days before treatment or before the first dose of study drug; (8) any syncope or seizure within 28 days before treatment; 14. History of severe hypersensitivity reaction to other monoclonal antibodies; 15. Received Chinese herbal medicine or Chinese patent medicine for cancer control within 14 days before the first dose of study drug; 16. Receiv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| One year-OS;One year-EFS; | — |
Countries
China
Contacts
Public ContactHang Zhou
Sichuan Cancer Hospital
Outcome results
None listed