Oral Cancer
Conditions
Interventions
Experimental group:Camrelizumab combined with Nedaplatin and Tiggio in the postoperative adjuvant treatment
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Have fully understood this research and voluntarily signed an informed consent form; 2.Aged 18 to 65 years; 3.Patients with advanced oral squamous carcinoma confirmed by pathological histology or cytology and after one surgery within 8 weeks with high risk factors (positive incision, lymph node envelope invasion or T3-4/N2-3, lymph nodes are located in zones IV or V, vascular invasion, peripheral nerve invasion); 4.ECOG:0-1 points; 5.Expected survival period of >= is 6 months; 6.The main organs function is normal, and the test results during screening must meet the following requirements: (1)Blood routine examination standard should meet the following criteria:(no blood transfusion and blood products within 14 days, not corrected using G-CSF and other hematopoietic stimulation factors): 1)Hemoglobin (Hb) >= 100 g/L; 2)Neutrophil number (ANC) >= 1.5x10^9/L; 3)Platelet count (PLT) >= 100 x10^9/L; (2)Biochemical examination shall meet the following criteria: 1)Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); 4)Urine routine tests showed urine protein (UPRO) =low normal limit (50%); (4)International Standardized Ratio (INR)<=1.5 x ULN and the activated partial prothrombin time <= 1.5 x ULN; 7.Contraception: Women of childbearing age should agree to adopt effective contraception during the study period and within 6 months after the study; The serum or urinary pregnancy test is negative within 7 days before the study group, and must be non-lactation patients; Men should agree to adopt contraception during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1.Patients are allergic to drug treatment; 2.Brain metastasis or spinal cord compression without surgical and / or radiation treatment, or previous treated brain metastasis or spinal cord compression, but no clinical imaging evidence of stability; 3.Cardiovascular diseases of significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina or coronary artery bypass grafting within 6 months before entry; congestive Heart Failure New York Heart Association (NYHA) grade >= 2; arrhythmia (including >= 470 ms for >= 450 ms, in QTc interval men); left ventricular ejection fraction (LVEF) 140mmHg or diastolic pressure> 90mmHg; 5.Routine urine protein >= + + and confirmed 24 hour urine protein quantitative> 1.0g; 6.Patients with a history of psychotropic substance abuse and who cannot be removed or have mental disorders; 7.Severe infection that is active or unable to control; 8.Patients have any history of active autoimmune disease or autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma has been completely relieved in childhood, no intervention in adults; asthma where patients need bronchodilator for medical intervention); 9.A significant history of liver disease is known, including but not limited to known hepatitis B virus (HBV) infection and HBV DNA positive (>=1 x10^4 copies / ml); known hepatitis C virus infection (HCV) and HCV RNA positive (>=1 x 10^3 / ml), or cirrhosis, etc.; 10.Patients who are using immunosuppressor, or systemic hormone therapy for immunosuppression purposes (dose> 10mg/ day prednisone or other efficacy hormones) and continue within 2 weeks prior to the group; 11.Patients with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug pneumonia, and severe lung function impairment; 12.Women with pregnancy (who have tested positive for pregnancy before medication) or who are breastfeeding; 13.Patients with other malignant tumors within 5 years; 14.Participating in interventional clinical research treatment, or receiving other trial drugs or research devices within 4 weeks prior to initial administration; not adequate recovery from toxicity and / or complications caused by any intervention (i. e., <= level 1 or at baseline, excluding fatigue or hair loss); 15.Patients with active attenuated vaccine within 30 days or expected during the study period; 16.The subject had or planned to undergo solid organ or blood system transplantation (except the corneal transplantation) during the study; 17.According to the judgment of the researchers, the patients who are not fit for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;2-year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactHe Wei
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed