Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

April 20, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

May 30, 2029

Conditions
Head and Neck Squamous Cell CarcinomaHead and Neck CancerHNSCCHead Cancer Neck
Interventions
DRUG

Carboplatin

Carboplatin AUC 5 on weeks 1, 3, and 6

DRUG

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

DRUG

Polymeric Micellar Paclitaxel

Polymeric Micellar Paclitaxel 300mg/mg/m2 on weeks 1, 3 and 6

PROCEDURE

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).

RADIATION

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.

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

NCT06366945 - Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC | Biotech Hunter | Biotech Hunter