head and neck squamous cell carcinoma
Conditions
Interventions
intervention group:Two cycles of pabolizumab (200mg) + docetaxel (75mg/m2) + cisplatin (75mg/m2) were administered before surgery
Sponsors
Hospital of Stomatology, Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed age 18-75 years old; 2. Untreated patients with locally advanced head and neck squamous cell carcinoma (III-IVB non-oropharyngeal or HPV-negative oropharyngeal cancer and II-III HPV-positive oropharyngeal cancer) diagnosed according to the 8th edition of the American Joint Committee on Cancer Clinical staging System and with potentially curative resection options were evaluated by a head and neck oncologic surgeon in Hospital of Stomatology, Wuhan University; 3. ECOG score: 0-1; 4. The related physiological indicators should meet the following criteria: neutrophil >=1.5×10^9 /L, hemoglobin concentration >=90g/L, platelet count >=100×10^9/L; Total bilirubin =30 g/L; Aspartate aminotransferase and/or alanine aminotransferase =60 mL/min; 5. Normal thyroid function (T3 and T4 levels should be examined if thyroid stimulating hormone is abnormal, and normal T3 and T4 levels can be included) and coagulation function; 6. The subjects were willing to participate in the study and were able to sign an informed consent form, be willing to accept pre-treatment biopsy and provide blood and tissue before treatment and at the time of surgery for the follow-up study, and were willing and able to comply with the follow-up, treatment, laboratory testing and other study requirements specified in the study protocol; 7. Electrocardiogram and chest imaging were normal. 8. Women and men of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier methods, etc.) from screening until 1 year after completion of treatment.
Exclusion criteria
Exclusion criteria: 1. Allergy to pembrolizumab, cisplatin and docetaxel; 2. Pregnant or lactating women; 3. Have active autoimmune diseases and a history of autoimmune diseases (including but not limited to hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc.); 4. Have a history of immunodeficiency disease (such as HIV), or have a history of organ transplantation or bone marrow transplantation, or are taking immunosuppressants; 5. Uncontrolled heart disease, such as New York Heart Association functional class >=2, unstable angina, and myocardial infarction in the past year; 6. Severe infection, major surgery, or trauma within 4 weeks before the first dose of study drug; 7. Participated in other clinical trials within 3 months before the start of the trial; 8. Other types of cancer or a history of other cancer within 5 years before the first use of study drug; 9. Received an antitumor vaccine or a live vaccine within 4 weeks before the first dose of study drug; 10. History of psychotropic drug abuse and drug use; 11. Poor control of diabetes, hypertension and other systemic diseases; 12. Other reasons for exclusion as deemed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 years overall survival;5 years disease-free survival;objective remission rate; | — |
Countries
China
Contacts
Public ContactZhe Shao
Hospital of Stomatology, Wuhan University
Outcome results
None listed