Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma

The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.

NCT Number	NCT06470217
Lead Sponsor	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions	Locally Advanced Head and Neck Squamous Cell Carcinoma
Enrollment	116 participants
Start Date	2024-06-19
Primary Completion	2025-06-19 (estimated)
Study Completion	2027-06-19 (estimated)
Updated on ClinicalTrials.gov	2025-02-11