Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
• 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