Trial intelligence / Profile preview

Cetuximab, Tislelizumab, and Chemotherapy for Unresectable LA HNSCC

NCT06978829Phase 2

Key facts

Status: Recruiting
Start: Mar 2025
Primary completion: Mar 2027
Countries: 1
Modality: Monoclonal Antibodies

Drugs: tislelizumab
Conditions: head and neck squamous cell carcinoma (HNSCC)

Overview

Phase 2, open-label, single-arm trial of tislelizumab in head and neck squamous cell carcinoma (HNSCC). Primary endpoint: Objective Response Rate at 6 months. Started Mar 2025; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental arm
Conversion therapy with TP+Cetuximab+Tislelizumab followed by local therapy and Tislelizumab maintenance.

Who it enrols

Patients with unresectable locally advanced head and neck squamous cell carcinoma, no prior treatment, ECOG 0-1, and adequate organ function.

Endpoints

Primary

Objective Response Rate6 months

Secondary

R0 Resection Rate6 months
Major Pathological Response Rate6 months
Progression-Free Survivalup to 5 years
Overall Survivalup to 5 years
Adverse Event Rateup to 2 years

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