Evaluating Trilaciclib with Chemoradiotherapy After Surgery for Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of trilaciclib combined with standard treatment as an additional therapy after surgery for patients with locally advanced head and neck squamous cell carcinoma. Trilaciclib, a CDK46 inhibitor approved by the FDA for small cell lung cancer, is being studied here for its potential to protect bone marrow during postoperative concurrent chemoradiotherapy. This phase 2, open-label, single-arm study focuses on patients who have undergone radical surgery and require postoperative chemotherapy and radiotherapy. Participants receive trilaciclib at 240 mgm through an intravenous infusion over 30 minutes, administered within 4 hours before each chemotherapy session. Cisplatin is given at 40 mgm intravenously over 2 to 3 hours, once weekly for 6 to 7 sessions. The study assesses this combined treatment during the postoperative concurrent chemoradiotherapy period, with no placebo or comparator group. Throughout the study, researchers monitor participants from enrollment until 15 days after completing chemoradiotherapy. They assess the occurrence of severe neutropenia as the primary outcome, along with other blood-related side effects such as thrombocytopenia, anemia, febrile neutropenia, and the need for blood transfusions. Participants undergo regular evaluations of blood counts, organ function, and safety, with total participation lasting through the treatment and immediate recovery phase.

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