Oral Cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years (including 18 and 70 years old); 2. Oral cancer patients diagnosed by histology or cytology, including tongue cancer, mouth floor cancer, gum cancer, cheek cancer, and palate cancer; 3. After surgical resection; 4. ECOG: 0-2 points; 5. Expected survival period >= 6 months; 6. The function of major organs is normal, that is, the following criteria are met: (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)HB>=90 g/L; 2) ANC>=1.5x10^9/L; 3) PLT>=80x10^9/L. (2) The biochemical examination shall meet the following standards: 1) TBIL45 ml/min (Cockcroft-Gault formula, see Annex 2). 6. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods during the trial and 8 weeks after the last administration of the trial drug contraception. For males, consent to use an appropriate method of contraception or be surgically sterilized during the trial and 8 weeks after the last dose of the trial drug; 7. The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. People with high blood pressure who cannot fall into the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 2. Past severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >=450 ms for males and >=470 ms for females); according to NYHA standards, grade ?IV Cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 3. Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour urine protein quantitative >1.0g); 4. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN) with bleeding tendency, or those who have had arterial/venous thrombosis within 12 months; 5. Long-term unhealed wounds or fractures; 6. According to the judgment of the investigator, there are other patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 7. Pregnant or breastfeeding women; 8. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;safety;1 year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactHe Wei
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed