RecruitingPhase 3NCT05582265

Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Head and Neck Squamous Cell Carcinoma (REDUCTION-I)

A Phase 3, Prospective,Multicenter, Randomized Open-Label Trial to Compare the Efficacy and Safety of Tislelizumab (BGB A317, Anti-PD1 Antibody) Combined With Chemotherapy Followed By Surgery Versus Up-Front Surgery as Treatment for Resectable Head And Neck Squamous Cell Carcinoma


Sponsor

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

Enrollment

537 participants

Start Date

Oct 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A prospective, randomized, open-label, multicenter Phase 3 trial designed to compare the safety and efficacy of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy (tislelizumab) combined with chemotherapy before surgery leads to better outcomes than going straight to surgery in people with resectable head and neck cancer. Researchers want to see if "priming" the immune system before surgery improves survival and cure rates. **You may be eligible if...** - You are 18–79 years old - You have confirmed head and neck squamous cell cancer, stage III or IVA, that can be surgically removed - You are in good physical condition - You have never received immunotherapy before (no prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs) - Your organ function (kidneys, liver) is adequate based on recent blood tests **You may NOT be eligible if...** - You have received prior immunotherapy for your cancer - You are 80 or older - Your cancer cannot be surgically removed - Your overall health is too poor to tolerate chemotherapy or surgery 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)

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

DRUGCarboplatin (adjuvant)

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


Locations(3)

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

Guanzhou, Guangdong, China

Zhong shan people's hospital

Zhongshan, Guangdong, China

Huazhong University of Science and Technology Union Hospital (Nanshan Hospital)

Shenzhen, Nanshan, China

View Full Details on ClinicalTrials.gov

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NCT05582265


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