squamous cell carcinoma of the head and neck
Conditions
Interventions
treatment group:Sintilimab+Paclitaxel +cisplatin
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All eligible patients included in this study must meet the following criteria: 1. Before the implementation of any test related processes, signed a written informed consent; 2. Both sexes, aged =18 years old; 3. Determine by histology or cytology, researchers evaluation for patients with locally advanced head and neck squamous cell carcinomas. Including oral and oropharyngeal cancer, stomach cancer, laryngeal cancer, etc.; 4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1); 5. Always do not accept any systemic anti-tumor treatment; 6. ECOG score 0-1; 7. The expected survival time > 6 months; 8. Adequate organ function, subject must meet the following laboratory indicators: 1) nearly 14 days without the use of granulocyte colony stimulating factor, neutrophils absolute value (ANC) acuity 1.5 x109 / L. 2) platelet count =100×109/L without blood transfusion in the past 14 days. 3) close to 14 days without blood transfusion or the use of erythropoietin, 9 g/dL or higher hemoglobin (90 g/L) or 5.6 or higher tendency/L; 4) Total bilirubin =1.5× upper limit of normal value (ULN); Or total bilirubin >1.5×ULN but direct bilirubin = ULN 5) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5×ULN, or =5×ULN in subjects with liver metastasis; 6) serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; 7) Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) =1.5 times ULN Or subjects are receiving anticoagulant therapy, but the prothrombin time (PT) or part of a clotting time (PTT) live enzymes within the scope of the intended use of anticoagulants therapy; • part activated clotting time (aPTT) live enzymes or part of a clotting time live enzymes (PTT) 1.5 x ULN or less; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the therapeutic range for the intended use of the anticoagulant; 8) normal thyroid function, defined as thyroid stimulating hormone (TSH) in the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range. 9) myocardial enzyme spectrum in the normal range (such as the comprehensive judgment to do not have exceptions are allowed into the clinical significance of pure laboratory group); 9. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days before receiving the first dose of study drug (day 1 of cycle 1). If urine pregnancy test result can't confirmed as negative, insist on blood pregnancy tests are carried out. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy. 10. Such as the risk of pregnancy all participants (no matter male or female) needs to be studied during the whole therapy until at the end of the treatment time 120 days after drug delivery (or 180 days) after the last chemotherapy drugs dosage used in contraception failure rate lower than 1%.
Exclusion criteria
Exclusion criteria: 1. The primary site for rhinitis or cutaneous squamous cell carcinoma patients, for the first time to give medicine five years before diagnosis of recurrent or metastatic head and neck squamous cell carcinomas patients with malignant tumor and the other did not cure (not including after cure skin basal cell carcinoma, squamous cell carcinoma of the skin, and/or after radical resection of carcinoma in situ); 2. The current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first dose received study used drugs or other treatments; 3. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137); 4. Received anti-tumor indications of Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin) systemic treatment within 2 weeks before the first dose; 5. For the first time to give medicine 2 years before happened need systemic treatment (for example, using alleviate disease drugs, corticosteroids or immunosuppressants) the sexual activity itself of immune diseases. , thyroid hormone replacement therapy (such as insulin or used for adrenal or pituitary insufficiency of physiologic glucocorticoid, etc.) shall not be regarded as systemic treatment; 6. Receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days before the first study dose; Note: allows the use of physiological doses of corticosteroids (10 mg/day or less prednisone or equivalent drugs); 7. The known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Those who have known the active ingredients or excipients of sintilimab in the study, or who are allergic to the chemotherapy drugs in the study; 9. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade =1 or baseline, excluding fatigue or alopecia); 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Untreated active hepatitis b (defined as HBsAg positive at the same time to detect HBV - DNA copy number is greater than the clinical laboratory's research center upper limit of normal). Note: in accordance with the following standards of hepatitis b patients can also into groups: 1) Subjects with HBV viral load <1000 copies /ml (200 IU/ml) before the first dose should receive anti-HBV therapy throughout the study drug treatment to avoid viral reactivation 2) For subjects with anti-HBc (+), HBsAg (-), anti-hbs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation should be closely monitored 12. Active HCV-infected subjects (HCV-antibody positive with HCV-RNA levels above the detectable range); 13. A live vaccine dose within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed. 14. Pregnant or lactating women; 15. There are no serious or uncontrolled systemic disease, such as: 1) significant rhythm, conduction or morphological abnormalities in resting ECG, such as complete left bundle branch block, = ? degree
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (objective response rate;pathological complete response rate;main pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactCao fangli
Qilu Hospital of Shandong University (Qingdao)
Outcome results
None listed