head and neck squamous cell carcinoma
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Wenzhou Medicine University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before implementing any procedures related to the trial; 2. No gender limitation, age =18 years old; 3. Patients with advanced head and neck squamous cell carcinoma confirmed by histology and cytology without any treatment, including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, etc. (excluding nasopharyngeal cancer), assessed by researchers as unresectable; 4. According to the solid tumor efficacy evaluation criteria (RECIST v1.1 edition), there is at least one radiographically measurable lesion; 5. ECOG score 0-1; 6. Expected survival time > 3 months; 7. For adequate organ function, subjects must meet the following laboratory criteria: 1) In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) was =1.5x109/L. 2) Platelets =100×109/L in the past 14 days without blood transfusion. 3) Hemoglobin =9 g/dL (90 g/L) or =5.6 mmol/L in the past 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin =1.5× upper limit of normal (ULN);Or total bilirubin >1.5×ULN but direct bilirubin = ULN 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2.5×ULN, or subjects with liver metastasis =5×ULN; 6) Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =60 ml/min; 7) Good coagulation function: • International Standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN;Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the therapeutic range of the anticoagulant's intended use; • Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) =1.5 times ULN;Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the therapeutic range of the anticoagulant's intended use; 8) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range.If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included); 8. For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 3 days prior to receiving the first 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; 9. 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: 1. Squamous cell carcinoma with a primary site of nasopharynx or skin. 2. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 3. Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Received systemic systemic treatment with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin) within 2 weeks before the first administration; 5. An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration.Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 6. Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the initial administration of the study; Note: The use of physiological doses of glucocorticoids (=10 mg/ day of prednisone or equivalent) is permitted; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Patients who are known to be allergic to the active ingredient or excipient of sintilimab in this study; 9. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 10. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1) HBV viral load <1000 copies /ml (200 IU/ml) prior to initial dosing, 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 11. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 12. Pregnant or lactating women; 13. Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment, and the investigator considers other potential risks unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Overall survival, OS;Survival at 12 months, 24 months;Progress free survival, PFS;Progress free survival at 12 months, 18months; | — |
Countries
china
Contacts
Public ContactChanglin Zou
The First Affiliated Hospital of Wenzhou Medicine University
Outcome results
None listed