MedTrace Logo

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

NCT06366945 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2024-04-16

No results posted yet for this study

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

Conditions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • jinsong li, doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2026-12-30
Completion
2029-05-30

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06366945 on ClinicalTrials.gov