Head and neck squamous cancer
Conditions
Interventions
experimental group:Paclitaxel (albumin-bound) + cisplatin + 5-FU
control group:paclitaxel+cisplatin+5-FU
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 and = 1.5*10^9 /L, platelet count >=100*10^9 /L, Hb >= 90 g / L, WBC >= 3.0 * 10^9 / L, and no bleeding tendency; 8. Liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) are 50 ml / min; 10. Need to determine HPV status by p16 IHC, in situ hybridization or by polymerase chain reaction-based assay; 11. Understand the circumstances of this study, patients and/or legal representatives voluntarily agree to participate in the trial and sign informed consent book.
Exclusion criteria
Exclusion criteria: 1. Patients with dyscrasia or multiple organ failure; 2. Patients with distant metastases; 3. The investigator believes that it will affect the subject's uncontrolled serious medical disease treated with the study protocol, such as a combination of serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infection, active peptic ulcer, etc.; 4. Dementia, mental state changes, or any mental illness that would prevent understanding or make informed consent or fill out a questionnaire; 5. Subjects with >= 2 peripheral neuropathy according to CTCAE V5.0; 6. History of allergies or hypersensitivity reactions to any of the therapeutic ingredients; 7. History of malignancy within 5 years prior to screening, including previous HNSCC primary tumors (except current HNSCC) with malignant tumors other than head and neck squamous cell carcinoma for the past 5 years, if eligible for all of the following criteria: Treatment of malignant tumors for the purpose of cure, such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery; and based on imaging follow-up results and No signs of recurrence or metastasis were found for any disease-specific tumor markers; 8. Any abnormal bone marrow hyperplasia and other hematopoietic dysfunction; 9. Patients with nasopharyngeal carcinoma; 10. Those who have received any other test drug treatment or participated in another interventional clinical trial within 30 days prior to screening; 11. Pregnant or lactating female patients; subjects of childbearing age who refuse to receive contraceptives; 12. The investigator believes that it is not suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;Progression-Free-Survival;overall survival;safety; | — |
Countries
China
Contacts
Public ContactMinghua Ge
Zhejiang Provincial People's Hospital
Outcome results
None listed