RecruitingPhase 2NCT06323369

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma


Sponsor

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

Enrollment

154 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment strategies for people with operable head and neck squamous cell cancer (stage III or IVA): receiving chemotherapy and an immunotherapy drug (tislelizumab) before surgery versus going straight to surgery. Researchers want to find out if giving immune-boosting treatment first leads to better outcomes. **You may be eligible if:** - You have been diagnosed with head and neck squamous cell cancer (stage III or IVA) and surgery is planned - You are between 18 and 79 years old - Your physical fitness score (ECOG) is 0 or 1 - Your cancer shows measurable disease on scans - You have not previously received immunotherapy drugs - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if:** - You have received prior immunotherapy (such as anti-PD-1 or anti-CTLA-4 drugs) - You have already had treatment for this cancer - Your organ function is too poor to tolerate treatment - Your cancer has spread to distant sites Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab(neoadjuvant)

Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUGCisplatin (neoadjuvant)

Cisplatin 75 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUGNab-paclitaxel (neoadjuvant)

Nab-paclitaxel 260mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

PROCEDURESurgical resection

Standard of care

DRUGCisplatin(adjuvant)

Cisplatin 100 mg/m2 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUGTislelizumab(adjuvant)

Tislelizumab 200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

RADIATIONRadiation

Recommended, standard of care

DRUGCarboplatin(neoadjuvant)

Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle

DRUGCarboplatin(adjuvant)

Cisplatin AUC=5 administered by intravenous (IV) infusion on Day 1 of each 21-day cycle


Locations(1)

Medical Ethics Committee of Sun Yat-sen Memorial Hospital

Guangzhou, Yuexiu, China

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NCT06323369


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