Study of Neoadjuvant Tirellizumab and Chemotherapy Followed by Surgery in Early Oral Squamous Cell Carcinoma T1-2N0M0

What this Trial Is About

Researchers are evaluating a treatment approach for patients with early-stage oral squamous cell carcinoma T1-2N0M0, focusing on whether adding neoadjuvant immunotherapy and chemotherapy before surgery improves outcomes compared to traditional surgery alone. This Phase 2 study addresses the issue that current methods cannot accurately predict hidden lymph node metastasis, leading to many patients receiving elective neck dissection that may not be necessary. The trial aims to explore the effectiveness of neoadjuvant treatment combined with surgery through comparing 2-year disease-free survival rates. Participants will be randomly assigned to one of two groups the experimental group receiving two cycles of neoadjuvant treatment with tislelizumab, carboplatin, and albumin-bound paclitaxel intravenously every 21 days, followed by enlarged local tumor excision with safe margins or the control group undergoing traditional surgery including primary tumor resection and selective neck dissection. This design allows comparison of the standard surgical approach with the addition of neoadjuvant immunotherapy and chemotherapy. During the study, researchers will collect tumor tissues, blood, saliva, and other samples to observe changes in imaging and pathology. They will also gather clinical information such as pathological grading, staging, and quality of life measures. The main outcomes include 2-year disease-free survival and quality of life, with secondary measures including 3-year overall survival and response rates. Participant monitoring includes laboratory tests and imaging assessments over the study period, which lasts several years with follow-up for survival and quality of life.

Neoadjuvant Tirellizumab Combined With Chemotherapy for Early Oral Squamous Cell Carcinoma(HNC-SYSU-004)