Neoadjuvant Immunochemotherapy With Tislelizumab, Albumin Paclitaxel and Cisplatin Followed by Standard Therapy Versus Standard Therapy for Locally Advanced Oral Squamous Cell Carcinoma A Multicenter Randomized Phase 3 Trial

What this Trial Is About

Researchers are evaluating the effectiveness of neoadjuvant immunochemotherapy using tislelizumab, albumin paclitaxel, and cisplatin followed by radical surgery and adjuvant therapy compared to standard treatment in patients with locally advanced and resectable oral squamous cell carcinoma (LAOSCC). This phase 3 randomized trial aims to determine if this combined approach improves 2-year survival rates and disease control compared to surgery and adjuvant therapy alone. Patients in the experimental group receive two cycles of neoadjuvant immunochemotherapy every three weeks, including intravenous albumin paclitaxel, cisplatin, and tislelizumab. Surgery is performed within two weeks after completing neoadjuvant therapy, involving radical resection and neck dissection with specific safety margins. Postoperative adjuvant therapy includes radiotherapy or chemoradiotherapy, with additional maintenance tislelizumab given every three weeks for one year in the experimental group. The control group receives standard radical surgery followed by adjuvant therapy without the neoadjuvant immunochemotherapy. Participants undergo baseline medical history and tumor assessments, including clinical and imaging evaluations before surgery. Pathological response after surgery is examined, and patients are monitored every three months for the first two years, then every six months for years three to five, and yearly thereafter. The study measures 2-year event-free survival, overall survival, disease-free survival, and major pathological response rates to assess the long-term benefits and safety of the treatment approach.

Neoadjuvant Immunochemotherapy for LAOSCC