Oral squamous cell carcinoma
Conditions
Interventions
None listed
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old and = 1.5 × 10^9/L; platelet (PLT) >= 100 × 10^9/L; hemoglobin >= 9 g/dL; (2) Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 2.8 g/dL; (4) Renal function: creatinine clearance rate (CCR) > 60 ml/min; (5) Coagulation function: international normalized ratio (INR) = 1.5; partial thromboplastin time (APTT) <= 1.5 × ULN; 5. The subjects voluntarily joined the study, signed the informed consent form, and were able to abide by the visits and related procedures stipulated in the protocol.
Exclusion criteria
Exclusion criteria: 1. History of other malignant tumors (non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal mucosal cancer, breast cancer, localized prostate cancer, etc. that have been cured and have not recurred within 5 years) except for the history of malignant tumors that the investigator believes can be included); 2. Any active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis , systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN) or Stevens- Johnson syndrome (except type 1 diabetes on stable doses of insulin); 3. People with allergic diseases, history of severe drug allergy, known allergy to macromolecular protein preparations (Note: severe allergy refers to allergy leading to hospitalization); 4. Received any of the following treatments: (1) Patients who have used chemotherapy drugs, PD-1 antibody, PD-L1 antibody, PD-L2 antibody, CTLA-4 antibody or EGFR antibody in the past; (2) Those who have been vaccinated with anti-tumor vaccines; (3) Any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) used within 4 weeks before the first administration or planned to be used during the study period; (4) Have undergone major surgery or severe trauma within 4 weeks before the first administration; (5) The toxicity of the previous anti-tumor therapy has not recovered to the level specified in the inclusion/exclusion criteria; 5. Those with serious medical diseases, such as grade II and above cardiac dysfunction (NYHA standard), ischemic heart disease (such as myocardial infarction or angina pectoris), clinically significant supraventricular or ventricular arrhythmia, controlled Poor diabetes (fasting blood glucose >= 10 mmol/L), poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg), echocardiogram showed ejection fraction 450 msec, women > 470 msec; abnormal electrocardiogram and the investigator believes that there is an additional risk to the trial drug; 6. Subjects with a known history of interstitial pneumonia, non-infectious pneumonia, or highly suspected interstitial pneumonia; or subjects who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity; Subjects with drug-induced or radiation-induced non-infectious pneumonia but asymptomatic subjects were enrolled; those with active pulmonary tuberculosis, or those who had a history of tuberculosis infection in the past but were not controlled after treatment; 7. Patients with hyperthyroidism and patients with organic thyroid disease cannot be enrolled, and hypothyroidism that can be controlled by thyroid replacement hormone therapy can be enrolled (whether it can be controlled is confirmed by the investigator and/or the Department of Endocrinology) ); 8. Active infection, or unexplained fever during the screening period and within 48 hours before the first administration, or use of systemic antibiotics within 1 week before signing the informed consent; 9. The subject has active hepatitis B (HBVDNA >= 2000 IU/ml or 104 copies/ml) or hepatitis C (hepatitis C antibody positi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactGuiquan Zhu
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed