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Trilaciclib for bone marrow protection in locally advanced head and neck cancer
NCT06752798Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2024
- Primary completion
- Sep 2025
- Countries
- 1
- Sponsor
- Hunan Cancer Hospital
- Modality
- Small Molecules
- Drugs
- trilaciclib
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of trilaciclib in head and neck squamous cell carcinoma (HNSCC), sponsored by Hunan Cancer Hospital. Primary endpoint: Incidence of Grade 3/4 Neutropenia. Started Dec 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Trilaciclib + Cisplatin
Trilaciclib administered prior to weekly Cisplatin during concurrent chemoradiotherapy
03
Who it enrols
Patients with pathologically confirmed locally advanced squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx) indicated for postoperative concurrent chemoradiotherapy. Must have high-risk features (e.g., positive margins, pT3-4, pN2-3). Excludes prior H&N treatment, HIV, active Hep B/C, and other malignancies.
04
Endpoints
Primary
Incidence of Grade 3/4 Neutropenia
Secondary
Incidence of Grade 3/4 Thrombocytopenia during Chemotherapy
Incidence of Grade 3/4 Anemia during Chemotherapy
Incidence of Febrile Neutropenia
Incidence of Platelet Transfusion
Incidence of Red Blood Cell Transfusion
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