Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Control group:Induction chemotherapy combined with immunotherapy:
Paclitaxel (albumin bound) 260mg/m^2, qd 1, Q3W×2 cycles Cisplatin 75mg/m^2, QD 1, Q3W×2 cycles
Finolizumab 200mg, given on day 1, Q3W
Experimental Group:Induction chemotherapy combined with high and low dose radiotherapy + immunotherapy:
Paclitaxel (albumin bound) 260mg/m^2 was given on day 1, Q3W×2 cycles
Cisplatin 75mg/m^2 was adm
Sponsors
Jiangxi cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Untreated, pathologically confirmed resectable squamous cell carcinoma of the head and neck (oral, oropharyngeal, hypopharyngeal, and laryngeal) 2. Clinical stage T1-2N1-3M0 or T3-4 any N, M0 (AJCC/UICC 8th) 3. Patients aged 18-70 years; 4.ECOG performance status (PS score) 0 or 1; 5. Major organ functions meet the following criteria: a. Neutrophil count >=1.5×10^9/L, hemoglobin >=90g/L and platelet count >=90×10^9/L; b. alanine aminotransferase (ALT)/ aspartate aminotransferase (AST)=60 ml/min (according to Cockcroft-Gault formula); 6. At least one measurable lesion according to RECIST1.1 criteria; 7. Expected survival time >=6 months; 8. Women of childbearing potential and male subjects of childbearing potential should use a medically accepted method of contraception for the duration of study treatment (at least 6 months after the last dose); 9. The subjects voluntarily participated in this study, signed the informed consent form, with good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous allergic history to any drug or its components in PD-1 monoclonal antibody, albumin-bound paclitaxel, and cisplatin; 2. The history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and thyroid papillary carcinoma; 3. Known major active infection, or the presence of major hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction or metabolic disorder as judged by the investigator, or other serious uncontrolled concomitant disease. 4. Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, organ transplantation history, or other immune-related diseases requiring long-term oral hormone therapy. 5. Patients with acute or chronic tuberculosis infection (positive T-spot test and suspicious chest X-ray lesions). 6. Known history of psychotropic drug abuse, alcoholism and drug use; 7. Pregnant or lactating women; 8. Other conditions that may affect subject safety or trial compliance as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main pathological response rates of the two groups of patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| The pathological complete response rates of the two groups of patients;The 2-year progression-free survival rate of the two groups of patients;The 2-year overall survival rate of the two groups of patients;The objective response rates of preoperative assessment for the two groups of patients;Treatment-related adverse events occurred in both groups of patients;The surgical delay rate of the two groups of patients (the proportion of patients whose surgery was more than 7 weeks after the last chemotherapy);The quality of life of the two groups of patients;Explore the relationship between biomarkers in tumor tissues and/or blood and immune efficacy; | — |
Countries
China
Contacts
Public ContactLi Jingao
Jiangxi cancer hospital
Outcome results
None listed