85
Participants
Start Date
April 20, 2024
Primary Completion Date
December 30, 2026
Study Completion Date
May 30, 2029
Carboplatin
Carboplatin AUC 5 on weeks 1, 3, and 6
Tislelizumab
Tislelizumab 200 mg on weeks 3, 6, and 9;if adjuvant immunotherapy is omitted, Tislelizumab will be administered on weeks 1, 3, 6, 9, 12, 15 after surgery
Polymeric Micellar Paclitaxel
Polymeric Micellar Paclitaxel 300mg/mg/m2 on weeks 1, 3 and 6
Surgical Resection of Primary +/- Neck Dissection
Twenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s).
Post-operative radiation therapy
Post-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic assesment following induction systemic therapy and surgery is ypT(pCR 或 MPR) and ypN(pCR) or ypT( pCR 或 MPR)and ypN( MPR)without the presence of Serious Adverse Event, adjuvant radiation will not be administered. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER