Squamous cell carcinoma of head and neck
Conditions
Interventions
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in this study, patients must meet all of the following criteria: 1. Sign a written informed consent prior to the implementation of any test-related procedures; 2. No gender limitation, age >= 18 years old, = 3 months; 8. Adequate organ function, the subject shall meet the following laboratory criteria: (1) The absolute value of neutrophil granulocyte (ANC) >= 1.5 x 10^9/L in the last 14 days without the use of granulocyte colony-stimulating factor. (2) Platelets >= 100×10^9/L without blood transfusion in the past 14 days. (3) Hemoglobin >= 9 g/dL (90 g/L) or >= 5.6 mmol/L without blood transfusion or use of erythropoietin within the last 14 days; (4) Total bilirubin 1.5 x ULN but direct bilirubin = 60 ml/min; (7) Good coagulation function: ? International Normalized ratio (INR) or prothrombin time (PT) <= 1.5 ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or partial thrombin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; ? Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) <= 1.5 ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thrombin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; (8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects whose baseline TSH is outside the normal range can be enrolled if total T3 (or FT3) and FT4 are within the normal range; (9) The myocardial enzyme profile was within the normal range (if the researchers comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included); 9. For female subjects of childbearing age, a urine or serum pregnancy test should be tested negative within 3 days prior to initial study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: Subjects who meet the following criteria are not eligible for inclusion in this study: 1. Squamous cell carcinoma of the nasopharynx or skin as the primary site. 2. Patients diagnosed with uncured malignancies other than squamous cell carcinoma of the head and neck within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 3. Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing; 4. Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulus or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); 5. Received systemic systemic therapy with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin) within 2 weeks before the first administration; 6. An active autoimmune immune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 7. Was receiving systemic glucocorticoid therapy (excluding nasal, inhalation, or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: Physiological doses of glucocorticoids (<= 10 mg/ day of prednisone or equivalent) are permitted; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Patients with known allergy to Sindillimab (drug study code: IBI308) and active ingredients or excipients of chemotherapy drugs; 10. Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., = grade 1 or baseline, excluding weakness or hair loss); 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive coupled with a detected HBV-DNA copy number greater than the upper limit of normal in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load < before initial administration; At 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout study drug therapy 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 close monitoring of viral reactivation is required 13. Active HCV-infected subjects (HCV antibody positive and HCV-RNA level above the lower limit of detection); 14. Received a live vaccine within 30 days prior to initial administration (cycle 1, day 1); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; But live attenuated influenza vaccines administered intranasally are not allowed. 15. Pregnant or lactating women; 16. There is any serious or uncontrolled systemic disease, such as: (1) The resting electrocardiogram (ECG)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Disease control rate;Overall survival;AEs; | — |
Countries
China
Contacts
Public ContactMan Hu
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed