Squamous cell carcinoma of the head and neck
Conditions
Interventions
Experimental group:Pembolizumab combined with Cisplatin and Paclitaxel in the neoadjuvant therapy
Sponsors
Liaoning Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with untreated stage IIIA-IVB head and neck squamous cell carcinoma (including oral cancer, hypopharyngeal cancer, and laryngeal cancer) diagnosed by histology and/or cytology 2. In the opinion of the investigator, he can safely receive pembrolizumab in combination with cisplatin and paclitaxel neoadjuvant therapy 3. Age= 18 years old 4.ECOG 0-1 5. Measurable disease as defined by RECIST v1.1 6. Have adequate bone marrow reserves and organ function: absolute neutrophil count (ANC) =1,000/microliter (mcL), platelet = 75,000/mcL, hemoglobin =8g/dL, no transfusion or erythropoietin (EPO)-dependent (within 7 days of assessment) 7. Renal function: serum creatinine = 1.5X upper limit of normal (ULN) OR measured or calculated creatinine clearance =60mL/min creatinine level> 1.5X institutional ULN. (GFR can also be used in place of creatinine or CrCl). Creatinine clearance should be calculated according to institutional standards 8. Liver function: for subjects with total bilirubin levels >1.5 ULN, serum total bilirubin =1.5X ULN or direct bilirubin =ULN; For patients with liver metastases, aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) = 2.5X ULNOR =5X ULN; Albumin > 2.5 mg/dL 9. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) = 1.5X ULN, if the subject receives anticoagulation therapy, PT or PTT is within the allowable range of anticoagulant use 10. Females should agree that contraception (such as intrauterine device (IUD), birth control pill or condom must be used for the duration of the study and for 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Males should agree to patients who must use contraception for the duration of the study and for 6 months after the end of the study period
Exclusion criteria
Exclusion criteria: 1. Patients who have been previously treated with PD-1 monoclonal antibody or similar drugs 2. Patients with a history of other (including unknown primary) malignant tumors within the previous 5 years. Note: Exceptions are adequately treated stage 1 or 2 basal/squamous cell carcinoma of the skin or carcinoma in situ receiving potentially curative therapy 3. Patients with known allergy to the study drug or its active ingredients and excipients 4. Patient with any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes mellitus, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring medication, liver, renal, or metabolic disease 5. Patients with underlying immunodeficiency, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases 6. Patients with underlying hematologic problems, including bleeding diathesis, known prior gastrointestinal bleeding requiring intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT) that is unstable in an anticoagulation regimen 7. Known history or any evidence of active non-communicable pneumonitis 8. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease 9. Concomitant (or receiving) treatment with drugs that may affect drug metabolism within 7 days prior to Day 1 of Cycle 1; 10. Pregnant or lactating, or expecting to become pregnant or give birth to a child during the projected trial period 11. Any uncontrolled intercurrent illness, including but not limited to persistent or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia 12. Extend the corrected QT (QTc) interval at 475 ms of screening EKG > 13. Ejection fraction by 2D echocardiography (ECHO) <40% at screening 14. Any serious medical or psychiatric illness/condition, including substance use disorder, that may, in the judgment of the investigator, interfere with or limit compliance with study requirements/treatment 15. Have an active autoimmune disease that has required systemic treatment (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response;2 year progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor regression grade;Overall survival;Distant disease free survival;Local Failure-Free Survival; | — |
Countries
China
Contacts
Public ContactZhendong Li
Liaoning Provincial Tumor Hospital
Outcome results
None listed