Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent Solid Tumor
Trilaciclib, an innovative first-in-class therapy that protects bone marrow at the source, has been approved for use in CDK4/6-independent small-cell lung cancer. However, clinical practice shows that patients with solid tumors frequently experience treatment-related pancytopenia involving neutrophils, erythroid lineag
| Condition(s) | Trilaciclib, CDK4/6-dependent Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Trilaciclib, an innovative first-in-class therapy that protects bone marrow at the source, has been approved for use in CDK4/6-independent small-cell lung cancer. However, clinical practice shows that patients with solid tumors frequently experience treatment-related pancytopenia involving neutrophils, erythroid lineage, and platelets after antineoplastic therapy, with a particularly high incidence of grade 3-4 myelosuppression. This poses serious threats to patient safety and delays the timely, standard administration of anticancer treatments. Therefore, it is imperative to investigate the expansion of trilaciclib's indications to solid tumors and its underlying mechanisms, and to establish a primary prophylaxis prediction model for solid tumor patients receiving chemotherapy. This study |
| Who can participate | Inclusion Criteria: * patients for whom primary prophylaxis with trilaciclib is indicated per Model A will receive primary prophylactic treatment. Exclusion Criteria: * patients for whom primary prophylaxis with trilaciclib is not indicated per Model A will receive secondary prophylaxis according to protocol. |
| Sex | All |
| Lead sponsor | Hebei Medical University Fourth Hospital |
| Locations | Shijiazhuang, Hebei, China |
| Start date | 2023-01-01 |
| NCT ID | NCT07490236 |
| Official listing | https://clinicaltrials.gov/study/NCT07490236 |