Neoadjuvant Personalized Anti-PD-1 and Anti-VEGFR Therapy in OSCC Patients

Prior treatment

• Toxicity of ≥ grade 2 (CTCAE 5.0) that has not subsided due to previous anticancer therapy
• Obvious cardiovascular abnormalities (such as myocardial infarction, superior vena cava syndrome, ≥ grade 2 heart disease diagnosed according to the NYHA classification criteria within 3 months prior to enrollment)
• Uncontrollable hypertension (systolic blood pressure \> after antihypertensive medication; 150mmHg and/or diastolic blood pressure \> 90mmHg) or clinically significant (such as activity) cardiovascular disease, such as cerebrovascular accident (≤ 6 months before screening), myocardial infarction (≤ 6 months before screening), unstable angina, congestive heart failure rated class II or above by NYHA, or severe arrhythmias that cannot be controlled or have a potential impact on trial treatment
• Participation in other clinical studies within 30 days prior to enrollment

Other illness

• Active severe clinical infection (\> NCI-CTCAE Version 5.0 level 2 infection)
• Has a history of maxillofacial and neck radiotherapy
• Other conditions that the investigator considers inappropriate for participation

Lab values

• Blood routine examination: WBC \< 3,000/mm3, hemoglobin \< 8g/L, platelet \< 80,000/mm3
• Liver function: ALAT/ASAT \> 2.5 times the normal upper limit, bilirubin \> 1.5 times the normal upper limit
• Renal function: serum creatinine \> 1.5 times the normal upper limit

Other

• Pregnant or lactating women

• Age: 18 to 75
• Gender: Male and female
• ECOG Score: 0-2
• Histologically confirmed primary oral squamous cell carcinoma (including tongue, gingival, buccal, oral base, hard palate, posterior molar area)
• Clinical stage III/IVA (cT1-2/N1-2/M0 or cT3-4a/N0-2 /M0, AJCC 8th)
• The combined positive score (CPS score) of PD-L1 expression \> 10
• Has signed informed consent