NCT06752798

Bone Marrow Protective Effect of Trilaciclib in Postoperative CCRT for LA-HNSCC

Bone Marrow Protective Effect of Trilaciclib in Postoperative Concurrent Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: An Open-Label, Single-Arm, Phase 2 Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as an adjuvant treatment for Head and neck cancer after surgery

Detailed description

Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression and approved by the FDA for small cell lung cancer patients in 2021.

Conditions

• Head and Neck Cancer Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Trilaciclib + Cisplatin	Trilaciclib: 240 mg/m², intravenous infusion over 30 minutes, administered within 4 hours prior to each chemotherapy session. Cisplatin: 40 mg/m², intravenous infusion over 2-3 hours, once a week, for a total of 6-7 times.

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

1 site across 1 country: China