RecruitingPhase 2NCT06752798

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


Sponsor

Hunan Cancer Hospital

Enrollment

30 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether trilaciclib — a drug that temporarily protects bone marrow — can reduce the blood cell damage (myelosuppression) caused by chemotherapy and radiation in patients with locally advanced head and neck squamous cell cancer after surgery. **You may be eligible if...** - You have confirmed squamous cell cancer of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) — not lip or nasopharynx - You have had radical (curative) surgery and are scheduled for post-operative chemotherapy plus radiation - You have specific high-risk features such as positive surgical margins or advanced lymph node spread - You are in good health (ECOG 0–1) with adequate blood counts and organ function **You may NOT be eligible if...** - You are pregnant or plan to become pregnant - Your blood counts or organ function fall outside required ranges - You have certain other conditions that make chemotherapy or radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib + 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.


Locations(1)

Hunan Cancer hospital

Changsha, Hunan, China

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NCT06752798


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