Oral cancer
Conditions
Interventions
Experimental group:Camrelizumab combined with apatinib mesylate
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Fully understand this research and sign the informed consent voluntarily; 2.Aged 18 to 75 years; 3.Patients with resectable oral cancer confirmed by histopathology or cytology; 4.ECOG score 0-1 points; 5.Expected survival period >= 6 months; 6.Has at least one measurable lesion (according to RECIST1.1); 7.The function of major organs is normal, and the test results at the time of screening must meet the following requirements: (1)The blood routine examination standards must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1)Hemoglobin (Hb) >= 90 g/L; 2)The number of neutrophils (ANC) >= 1.5x10^9/L; 3)Platelet count (PLT) >= 80x10^9/L. (2)The biochemical examination shall meet the following standards: 1)Total bilirubin (TBIL) 60ml/min (Cockcroft-Gault formula); 4)Urine routine test results show urine protein (UPRO) = the lower limit of normal (50%); (4)International Normalized Ratio (INR)<=1.5xULN and activated partial thromboplastin time<=1.5xULN. 8.Contraception: women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study; serum or urine pregnancy test negative within 7 days before study enrollment, and must be non-breastfeeding patients; Men should agree to patients who must use contraception during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1.Patients who are allergic to therapeutic drugs; 2.Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass surgery within 6 months before enrollment; congestive heart failure New York Heart Association (NYHA) classification >= 2 grade; arrhythmia (including QTc interval >= 450 ms in men and >= 470 ms in women); left ventricular ejection fraction (LVEF) 140mmHg or diastolic blood pressure>90mmHg; 4.Urine routine indicates urine protein >=++, and confirmed 24-hour urine protein quantitative > 1.0g; 5.Surgical operations (except biopsy) were performed within 28 days before enrollment in this study or the surgical incision was not completely healed; 6.Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 7.Patientts with a history of psychotropic drug abuse and unable to quit or have mental disorders; 8.Active or uncontrolled serious infection; 9.The patient has any active autoimmune disease or has a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; patients with complete remission of asthma in childhood and without any intervention in adulthood can be included; patients with asthma requiring bronchodilator medical intervention cannot be included); 10.Known significant history of liver disease, including but not limited to known hepatitis B virus (HBV) infection and HBV DNA positive (>=1x10^4 copies/ml); known hepatitis C virus infection ( HCV) and HCV RNA positive (>=1x10^3/ml), or liver cirrhosis, etc.; 11.The patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent hormones), and continues to use it within 2 weeks before enrollment; 12.Patients with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe pulmonary function damage; 13.Patients who are vaccinated with live attenuated vaccine within 30 days of the first medication or expected to be vaccinated within the study period; 14.Women who are pregnant (positive pregnancy test before taking the drug) or are breastfeeding; 15.Currently participating in interventional clinical research treatment, or receiving treatment with other experimental drugs or research devices within 4 weeks before the first dose; before the first dose, there has been no evidence of toxicity and/or complications caused by any intervention measures Adequate recovery (ie, <= grade 1 or at baseline, excluding fatigue or alopecia); 16.The subjects have received or plan to receive solid organ or blood system transplantation (except corneal transplantation) during the study period; 17.According to the judgment of the investigator, patients who are considered unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete pathological remission;overall survival;1-year disease-free survival rate;objective response rate;safety; | — |
Countries
China
Contacts
Public ContactHan Xinguang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed