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

NCT05582265 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 537

Last updated 2024-05-17

No results posted yet for this study

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.

Conditions

  • Head and Neck Squamous Cell Carcinomas

Interventions

DRUG

Tislelizumab（neoadjuvant）

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

DRUG

Cisplatin （neoadjuvant）

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

DRUG

Nab-paclitaxel （neoadjuvant）

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

PROCEDURE

Surgical resection

Standard of care

DRUG

Cisplatin（adjuvant）

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

DRUG

Tislelizumab（adjuvant）

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

RADIATION

Radiation

Recommended, standard of care

DRUG

Carboplatin (neoadjuvant）

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

DRUG

Carboplatin (adjuvant）

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

Sponsors & Collaborators

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Shenzhen Sixth People's Hospital

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Song Fan, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2028-10-31
Completion
2030-10-31

Countries

  • China

Study Locations

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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 NCT05582265 on ClinicalTrials.gov