Head and neck squamous carcinoma
Conditions
Interventions
Experimental group:Pabrolizumab combined with low-dose cisplatin and 5-fluorouracil + surgery or radiation therapy + pabolizumab single agent maintenance
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years and =1.5x 10^9 /L, platelet count >=100 x 10^9 /L, Hb >= 90 g/L, WBC >= 3.0x 10^9 /L before enrollment, and no bleeding tendency. 10. Liver function tests: glutamic aminotransferase (ALT), glutamic aminotransferase (AST), alkaline phosphatase (ALP) are 50 ml/min. 12. HPV status determined by p16 IHC, in situ hybridization or by polymerase chain reaction-based assay is required. 13. able to understand the study and the patient and/or legal representative voluntarily agree to participate in this trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with cachexia or multi-organ failure. 2. Patients with distant metastases. 3. Serious uncontrolled medical conditions that in the opinion of the investigator would interfere with the subject's ability to be treated by the study protocol, such as comorbid serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc. 4. Dementia, altered mental status or any mental illness that would prevent understanding or giving informed consent or completing questionnaires. 5. Subjects with >= grade 2 peripheral neuropathy according to CTCAE V5.0 6. History of allergy or hypersensitivity reaction to any therapeutic component 7. History of malignancy within 5 years prior to screening, including prior HNSCC primary tumors (in addition to current HNSCC) prior malignancy other than head and neck squamous carcinoma within 5 years. Eligibility if all of the following criteria are met: treatment of malignancy for curative purposes, such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, limited prostate cancer after radical surgery, and ductal carcinoma in situ of the breast after radical surgery; along with no signs of recurrence or metastasis based on imaging follow-up and any disease-specific tumor markers. 8. Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS). Note: HIV testing must be performed at a locally defined site. 9. Patients with nasopharyngeal carcinoma 10. who have been treated with any other experimental drug or participated in another interventional clinical trial within 30 days prior to screening 11. Participants requiring systemic treatment with glucocorticoids (>10 mg prednisone equivalent dose per day) or other immunosuppressive drugs within 14 days prior to randomization. In the absence of active autoimmune disease, inhaled or topical steroids, and adrenal hormone replacement therapy at >10 mg prednisone equivalent dose per day are allowed. 12. Female patients who are pregnant or lactating; subjects of childbearing age who refuse to accept contraception. 13. Those who are considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor descending stage condition;One-year local control rate; | — |
Countries
China
Contacts
Public ContactMinghua Ge
Zhejiang Provincial People's Hospital
Outcome results
None listed