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

NCT06323369 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-05-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2029-03-25
Completion
2029-09-25

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT06323369 on ClinicalTrials.gov