Head and neck squamous cell carcinoma
Conditions
Interventions
single:A 3-week treatment cycle is administered at the following doses.
Paclitaxel polymer micelles for injection 230 mg/m2 intravenous infusion = 3 hours, d1, without the need for a special infusion
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 80 years old>= age >= 18 years old, male or female; 2. Patients with histopathologically or cytologically confirmed head and neck squamous cell carcinoma; 3. Clinical phase II to IV.B without distant metastases (AJCC 8th); 4. Patients who have not received prior chemotherapy and have been initially treated with radiotherapy; 5. ECOG score of 0 or 1; 6. Normal bone marrow reserve function and normal liver and kidney function; 7. Expected survival time>= 3 months; 8. Subjects of childbearing age must agree to take effective contraceptive measures during the trial, and women of childbearing age must have a negative serum or urine pregnancy test 72 hours before the start of chemotherapy; 9. Subjects have good compliance, are able to carry out treatment and follow-up, and voluntarily comply with the provisions of this study; 10. Subjects voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastases; 2. Presence of uncontrolled serious medical diseases, such as serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; 3. Presence of dementia, altered mental status, or any psychiatric illness that would preclude understanding or taking informed consent or filling out questionnaires; 4. Subjects with Grade >=2 peripheral neuropathy according to CTACE V5.0; 5. Malignant tumors other than head and neck squamous cell carcinoma within the past 5 years, except for adequately treated basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; 6. History of allergy or hypersensitivity to any of the therapeutic components; 7. Abnormal results of physical examination and laboratory tests: (1) Hematologic dysfunction is defined as: 1)Absolute neutrophil (ANC) count: 1.5 times the upper limit of normal (ULN); 2)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 2.5 times the ULN, >or 5 times the ULN if liver metastases are present; (3) Definition of abnormal renal function: Serum creatinine > 1.5 times ULN, or calculated creatinine clearance < 50ml/min; 8. Those who need to be combined with other anti-tumor drugs; 9. Have received any other investigational drug treatment or participated in another interventional clinical trial within 30 days prior to screening; 10. In the opinion of the investigator, it is not suitable for enrollment; 11. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesions; | — |
Countries
China
Contacts
Public ContactZhang Wenchao
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed