head and neck squamous cell carcinoma
Conditions
Interventions
group A:sintilimab+chemotherapy
Sponsors
The First Affiliated Hospital of Wenzhou Medicine University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent prior to the implementation of any test related procedures; 2. No gender limit, aged >=18 years; 3. The subject was histologically or cytologically identified as having relapsed or metastatic squamous cell carcinoma of the head and neck., including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, etc. (excluding nasopharyngeal cancer); 4. According to the solid tumor efficacy evaluation criteria (RECIST v1.1 version), there was at least one radiographically measurable lesion; 5. PD-L1 protein test CPS score >=1; 6. ECOG score 0-1; 7. Expected survival time > 3 months; 8. Adequate organ function, subject shall meet the following laboratory criteria: (1) The absolute value of neutrophil granulocyte (ANC) >=1.5x10^9/L in the last 14 days without the use of granulocyte colony stimulating factor; (2) Platelets >=100x10^9/L without blood transfusion in the last 14 days; (3) Hemoglobin >=9 g/dL (90 g/L) or >=5.6 mmol/L in the last 14 days without blood transfusion or use of erythropoietin; (4) Total bilirubin ULN but direct bilirubin =60 ml/min; (7) Good coagulation function: 1) International Normalized ratio (INR) or prothrombin time (PT) <=1.5 times 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; 2) 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 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 negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as having been postmenopausal for at least one year or having undergone surgical sterilization or hysterectomy.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma of the nasopharynx or skin as the primary site; 2. Currently participating in an interventional clinical study, or receiving other investigational drugs or using 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 synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137); 4. 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; 5. 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; 6. Being treated with systemic corticosteroids (excluding intranasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (<=10 mg/ day of prednisone or equivalent) are permitted; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Subjects who are known to be allergic to the active ingredient or excipients of the drug sindillizumab 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 coupled with a detected HBV-DNA copy number 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 level above the lower limit of detection); 12. Medical history or evidence of disease that may interfere with test results, prevent subjects from fully participating in the study, abnormal values of treatment or laboratory tests, 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; | — |
Countries
China
Contacts
Public ContactZou Changlin
The First Affiliated Hospital of Wenzhou Medicine University
Outcome results
None listed