Head and neck squamous cell carcinoma
Conditions
Interventions
TP53mutPIK3CAmut/amp group:Bolivizumab + standard chemotherapy (cisplatin/carboplatin + paclitaxel)
TP53wtPIK3CAwt group:Bolivizumab + standard chemotherapy (cisplatin/carboplatin + paclitaxel)
TP53wtPIK3CAmut/amp group:Bolivizumab + standard chemotherapy (cisplatin/carboplatin + paclitaxel)
TP53mutPIK3CAwt group:Bolivizumab + standard chemotherapy (cisplatin/carboplatin + paclitaxel)
Sponsors
Beijing Tongren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects with only locally recurring head and neck squamous cell carcinoma (including oral cancer, hypopharyngeal cancer, and laryngeal cancer) diagnosed by histology and/or cytology; 2. It has not progressed after receiving platinum-containing chemotherapy for at least 6 months; 3. The investigator believes that it can safely receive Pembrolizumab combined with standard chemotherapy (cisplatin/carboplatin + paclitaxel) treatment; 4. Aged >= 18 years; 5. ECOG 0-1; 6. Measurable diseases defined by RECIST v1.1; 7. Detection of HPV status of oropharyngeal cancer; 8. Sufficient bone marrow reserve and organ function: absolute neutrophil count (ANC) >= 1,000/microliter (mcL), platelet >= 75,000/mcL, hemoglobin >= 8g/dL, and no blood transfusion or erythropoietin (EPO) dependence (within 7 days after evaluation); 9. Renal function: serum creatinine = 60 mL/min creatinine level> 1.5X ULN. (GFR can also be used instead of creatinine or CrCl). Creatinine clearance rate should be calculated according to institutional standards; 10. Liver function: for subjects with total bilirubin level > 1.5 ULN, serum total bilirubin 2.5 mg/dL; 11. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) =1.5 x 10^9/L, platelet (PLT) >= 100 x 10^9/L, hemoglobin (Hb) >= 90g/L; (2) Liver function: when total bilirubin (TBIL)1.5xULN, direct bilirubin =60 ml/min, creatinine>1.5xULN; (4) Blood coagulation function: activated partial thromboplastin time (APTT) =50%; 14. Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received PD-1 monoclonal antibody or similar drugs in the past; 2. Suffered from disease progression (PD) within six (6) months after the completion of radical systemic treatment of locally advanced HNSCC; 3. Life expectancy is less than 3 months and/or disease progresses rapidly; 4. Patients who are known to be allergic to the study drug or its active ingredients and excipients; 5. The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia, liver, kidney, or metabolic diseases need medical treatement; 6. Patients with latent immune deficiency, chronic infection, including HIV, hepatitis, tuberculosis (TB) or autoimmune diseases; 7. Patients with underlying hematological problems, including bleeding diathesis, known prior gastrointestinal bleeding requires intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT) is not included in the anticoagulation regimen stability; 8. Known medical history or any evidence of active non-communicable pneumonia; 9. Known active central nervous system (CNS) metastasis and/or cancerous meningitis or leptomeningopathy. Subjects with previously treated brain metastases can participate as long as they are stable (There is no evidence of imaging progression at least four weeks before the first trial treatment and any neurological symptoms have returned to baseline), and there is no evidence of new or enlarged brain metastasis, and steroids were not used for at least 7 days before the trial treatment. This exception does not include cancerous meningitis, which is excluded regardless of clinical stability; 10. Simultaneously (or receive) treatment with drugs that may affect drug metabolism within 7 days before the first day of the first cycle; 11. Any uncontrolled concurrent disease, including but not limited to continuous or active infection, symptomatic congestive heart failure, unstable angina, and arrhythmia; 12. Extend the corrected QT (QTc) interval when screening EKG> 475 ms; 13. The ejection fraction through 2D echocardiography (ECHO) during screening is less than 40%; 14. Any serious medical or mental illness/illness, including substance use disorders, may interfere with or restrict compliance with research requirements/treatments in the researchers judgment; 15. Has an active autoimmune disease that requires systemic treatment (ie use of disease modifiers, corticosteroids or immunosuppressive drugs) in the past 2 years. Replacement therapy (for example, thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate(ORR) ;Quality of life (QOL);Safety; | — |
Countries
China
Contacts
Public ContactZhang Shurong
Beijing Tongren Hospital
Outcome results
None listed