NCT06323369View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

March 25, 2024

Primary Completion Date

March 25, 2029

Study Completion Date

September 25, 2029

Conditions
Head and Neck Squamous Cell Carcinoma
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）

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

DRUG

Carboplatin（adjuvant）

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

Trial Locations (1)

510120

RECRUITING

Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Guangzhou

All Listed Sponsors
lead

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

OTHER