Localized advanced head and neck squamous cell carcinoma
Conditions
Interventions
Test Group:Received 3 cycles of treatment with combination of cyparizumab, albumin bound paclitaxel, and cisplatin
Sponsors
Changzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 70 years old; 2. The enrolled patients must meet the criteria of stage III-IVb (AJCC 8th edition) for head and neck squamous cell carcinoma (non nasopharyngeal carcinoma); 3. No history of malignant tumors or related treatment history in the past; 4. Have not experienced congestive heart failure, unstable angina, or unstable arrhythmia within the past 6 months; 5. The patient's activity status score is 0-3 using the Eastern Cooperative Oncology Group (ECOG) scoring system, with an estimated life expectancy of = 3 months; 6. No severe hematopoietic function, heart, lung, liver, kidney dysfunction, or immune deficiency in the past; 7. One week before enrollment, the absolute value of T lymphocytes should be = 0.5 times the lower limit of normal values, and neutrophils should be = 2.0 × 109/L; AST and ALT = 3.0 times the upper limit of normal values; Creatinine = 3.0 times the upper limit of normal value; 8. Patients must have the ability to understand and voluntarily sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Have a history of malignant tumors and related treatments in the past; 3. Individuals with a history of uncontrolled epilepsy, central nervous system disease, or mental disorders, whose clinical severity may hinder the signing of informed consent forms or affect the patient's compliance with medication treatment, as determined by the researcher; 4. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medication intervention, or a history of myocardial infarction within the past 12 months; 5. Organ transplantation requires immunosuppressive therapy; 6. Known major active infections, or researchers determining the presence of significant blood, kidney, metabolic, gastrointestinal, endocrine or metabolic disorders, or other serious uncontrolled comorbidities; 7. Individuals who are allergic to any research medication ingredients; 8. Individuals with a history of immunodeficiency, including those who test positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation, or have other immune related diseases that require long-term oral hormone therapy; 9. During the period of acute or chronic tuberculosis infection (T-spot test positive, patient with suspicious tuberculosis lesions on chest X-ray); 10. Other situations that the researcher deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;R0 resection rate;progression free survival;overall survival;The incidence of treatment-related toxic reactions; | — |
Countries
China
Contacts
Public ContactJiang Wenjie
Changzhou First People's Hospital
Outcome results
None listed