oral cavity carcinoma
Conditions
Interventions
Control group:postoperative adjuvant radiotherapy without high risk factors
If there are high risk factors, postoperative adjuvant radiotherapy should be concurrent with cisplatin.
Experiment Group:if there is no high risk factor, postoperative adjuvant radiotherapy was performed, and Nitozumab 200 mg QW (6 cycles) was synchronized
If there are high risk factors, concurrent postoperative adjuvant radiotherapy with cisplatin and nituzumab 200 mg QW (6 cycles). After radiotherapy, the maintenance phase was sta
Sponsors
Peking University Hospital of Stomatology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects must be willing and able to comply with the interview, treatment plan, laboratory testing and other requirements in the research plan by signing a written informed consent before the study is included in the study; 2. The criteria for surgical resection should meet the following three points: no invasion of important structures, including internal carotid artery, common carotid artery, skull base bone, cervical vertebra, pleura, and mediastinum; No subcutaneous metastasis; The body can tolerate general anesthesia. 3. Oral mucosa squamous cell carcinoma confirmed by histology, stage III/IV, and no distant metastasis (M0); 4. Patients with ECOG physical condition score of 0-2; 5. Patient age = 18 years; 6. Safety index (obtained within 14 days before the study was included, and the detection value was within the following specified range): (1) Leukocyte = 2000/ µ L(2.0 × 109/L) (2) Neutrophils = 1500/ µ L(1.5 × 109/L) (3) Platelet = 100 × 103/ µ L(100 × 109/L) (4) Hemoglobin = 9.0 g/dL (90 g/L) or = 5.6 mmol/L (5) Serum creatinine 40 mL/min (using Cockcroft Gault formula): Female CrCl=(140 age) × Weight (kg) × 0.85 / (72 × Scr mg/dl) Male CrCl=(140 age) × Weight (kg) × 1.00 / (72 × Scr mg/dl) (6)ASTALT=3 × ULN (7) Total bilirubin = 1.5 × ULN (except Gilbert syndrome) (8) Resting blood oxygen saturation = 92%
Exclusion criteria
Exclusion criteria: 1. Patients with squamous cell carcinoma of unknown primary focus; 2. Uncontrolled patients with malignant tumors in the past three years; 3. Patients with a history of primary immunodeficiency or allograft transplantation; 4. Live attenuated vaccine was given within 30 days; 5. Have untreated and/or uncontrollable cardiovascular disease, and/or symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the past year or ventricular arrhythmia requiring drug treatment, and have a history of 2 or 3 degree atrioventricular block); 6. Patients with interstitial lung disease; 7. Pregnant or lactating women; 8. Those with uncontrolled symptoms related to adverse reactions of the test drug; 9. Physical and laboratory test results: a) known positive test history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); b) Any level 4 laboratory abnormality; 10. Allergy and adverse drug reactions: there is a history of allergy to test drug ingredients; 11. There are active severe clinical infections, including active tuberculosis. 12. Patients who have received new adjuvant therapy for head and neck tumors. 13. Patients with a history of head and neck radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;adverse event; | — |
Countries
China
Contacts
Public ContactZhang Jie
Peking University Hospital of Stomatology
Outcome results
None listed