Phase III Study of Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Compared to TP Chemotherapy or Surgery Alone in Treatable Advanced Oral Squamous Cell Carcinoma

What this Trial Is About

Researchers are investigating the survival benefits of combining neoadjuvant anti-PD-1 immunotherapy with TP chemotherapy compared to TP chemotherapy alone or immediate surgery in patients with resectable locally advanced oral squamous cell carcinoma. This Phase III study aims to verify the effectiveness and safety of this combined treatment and explore immune cell changes in tumors, lymph nodes, and blood related to patient response and prognosis. Participants are divided into three groups one receives radical surgery followed by radiotherapy or chemoradiotherapy as needed another receives two cycles of TP chemotherapy before surgery and possible postoperative therapy the third group receives three doses of anti-PD-1 immunotherapy plus two cycles of TP chemotherapy before surgery and subsequent radiotherapy or chemoradiotherapy if required. The chemotherapy drugs include docetaxel and cisplatin given by intravenous infusion, and the immunotherapy drug camrelizumab is also administered intravenously every two weeks. During the study, participants will undergo surgery and may receive additional radiotherapy or chemoradiotherapy. Researchers will assess event-free survival over 24 months as the primary outcome and monitor overall survival, radiographic and pathological responses, and adverse events throughout the study period. The trial involves detailed evaluations of immune responses and patient prognosis, with the total follow-up lasting up to two years after treatment.

Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma