Comparing Neoadjuvant Toripalimab Plus Albumin Paclitaxel and Cisplatin With Docetaxel, Cisplatin, and 5-Fluorouracil for Locally Advanced Oral Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the pathological effectiveness and safety of a new combination treatment called neoadjuvant Toripalimab with Albumin paclitaxel and Cisplatin TTP compared to the standard chemotherapy regimen Docetaxel, Cisplatin, and 5-fluorouracil TPF in patients with locally advanced, resectable oral squamous cell carcinoma OSCC. This study aims to find a better pre-surgery treatment approach to improve outcomes for these patients, building on earlier promising results from a smaller trial. Participants will be randomly assigned to one of two groups. The first group receives two cycles of intravenous Albumin paclitaxel, Cisplatin, and Toripalimab on days 1 and 22. The second group receives two cycles of intravenous Docetaxel and Cisplatin on days 1 and 22, plus 5-fluorouracil as a continuous infusion for five days during each cycle. After these treatments, all participants undergo surgery and may receive additional therapy as needed. During the study, participants will be closely monitored for their major pathological response three months after treatment begins. Researchers will also track disease-free survival and overall survival over two years. Assessments include physical exams, lab tests, and imaging to evaluate tumor response and safety. The total study duration extends up to about five years, including follow-up for long-term outcomes.

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