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NOT YET RECRUITING
NCT06366945
PHASE2

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

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

View on ClinicalTrials.gov

Summary

To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis

Official title: Prospective, Single-arm, Phase II Clinical Study of Tirellizumab Combined With Carboplatin and Paclitaxel Polymer Micelles Neoadjuvant Therapy for cN+ Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2024-04-20

Completion Date

2029-05-30

Last Updated

2024-04-16

Healthy Volunteers

No

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.