A Single-center Exploratory Clinical Study of Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma (cT1-2N0M0)
Surgery is usually the first choice for early-stage oral squamous cell carcinoma (OSCC). However, there is currently a lack of consensus on whether patients with clinically negative cervical lymph nodes (N0) should undergo elective neck dissection (END) at the same time. About 20-30% of cT1-2N0M0 oral cancer patients have occult lymph node metastasis, and existing examination methods cannot accurately predict occult cervical lymph node metastasis. Therefore, most clinical retrospective and prospective studies recommend END for cN0 patients. Previous studies have found that no cancer cells were found in the cervical lymph nodes of 70% of patients after END. This unselective END can cause patients with accessory nerve dysfunction, neck scars, etc., and prolong hospitalization and surgery time. Exploring the treatment model for patients with early-stage oral squamous cell carcinoma is an urgent problem that needs to be solved. This study intends to conduct a study on the neoadjuvant treatment of tislelizumab, carboplatin, and albumin-bound paclitaxel. After neoadjuvant immunotherapy in patients with early-stage oral cancer (T1-2N0M0), the primary tumor is treated with standard surgical treatment. Comparison with A single-center exploratory clinical study of traditional oral cancer radical resection + selective neck lymphadenectomy was conducted to explore its effectiveness through the difference in 2-year disease-free survival (DFS). This research plan covers 40 patients with early-stage oral squamous cell carcinoma. They will be randomly divided into tislelizumab, chemotherapy combined with surgery (experimental group) and traditional surgery (control group) in a 1:1 ratio. The patients' tumors will be collected. Tissues, adjacent cancer tissues, whole blood samples, saliva samples, and matrix samples were used to observe the changes in imaging and pathology compared with treatment. At the same time, the clinical information of the patients was collected, such as quality of life indicators such as judgment function, pathological grading, staging, treatment, Spine, serology, imaging, etc., mainly to evaluate the 2-year event-free survival (EFS) between the experimental group and Weather Forecast, and the 3-year overall survival (OS) and patient quality of life between the experimental group and Weather Forecast.
• Patients with early oral squamous cell carcinoma diagnosed as T1-2N0M0 according to the eighth edition of AJCC classification;
• No history of other malignant tumors;
• 18-75 years old;
• Baseline inspection is normal:
‣ The absolute value of neutrophil (ANC) ≥1.5x109/L in the past 14 days without the use of granulocyte colony-stimulating factor;
⁃ Platelets ≥100×109/L without blood transfusion in the past 14 days;
⁃ In the case of no blood transfusion or use of erythropoietin in the last 14 days, hemoglobin \> 9g/dL;
⁃ Total bilirubin ≤1.5× upper limit of normal (ULN);
⁃ Aspartate aminotransferase (AST), alanine aminotransferase (ALT) in ≤2.5×ULN (patients with liver metastases allowed ALT or AST ≤5×ULN);
⁃ Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
⁃ Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
⁃ Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
⁃ The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to enter the group);
‣ For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the result is negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;
‣ If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
• Sign informed consent.