Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC

Prior treatment

• Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments
• Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
• Patients receiving immunology-based treatment for any reason
• Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
• Uncontrollable hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment
• Participation in other clinical trials within 30 days before enrollment

Other illness

• Known allergic reaction to any ingredients or excipients of the therapy
• Known history of malignancy, unless been cured and no recurrence for 5 years
• Known history of radiation to head and neck
• Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
• Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation

Other

• Pregnant or lactating women
• Other situations that the investigator considers unsuitable with respect to participating in the trial

• Age: 18-75 years old
• Gender: male and female
• Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
• Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
• Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
• Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
• Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal
• Renal function: Serum creatinine \<1.5 times the upper limit of normal
• Coagulation function: INR, PT, APTT\<1.5 times the upper limit of normal
• Signed the informed consent form