With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice. Beyond conventional chemotherapy combination regimens, the integration of radiotherapy into multimodal treatment strategies has also expanded significantly.
While robust evidence supports the use of romiplostim for managing chemotherapy-induced thrombocytopenia (CIT), there is currently no clinical research evaluating its efficacy in treating thrombocytopenia associated with radiotherapy-combined treatment regimens in solid tumors.
To address this unmet clinical need, this study aims to evaluate the safety and efficacy of romiplostim N01 for injection in the treatment of radiotherapy-combined regimen-induced thrombocytopenia in solid tumor patients. The findings will establish evidence-based management strategies to optimize clinical decision-making in this context.
Age ≥18 years, regardless of gender; Histopathologically confirmed solid tumor patients (including but not limited to nasopharyngeal carcinoma, lung cancer, breast cancer, etc.);
Prior radiotherapy (RT) ≥45Gy (including standalone RT, concurrent/sequential chemoradiotherapy, or RT combined with other antitumor therapies, with treatment duration ≥2 weeks), regardless of prior induction/adjuvant chemotherapy;
Platelet count <75×10⁹/L within 3 days prior to enrollment, occurring during RT or within 1 month post-RT;
Estimated survival ≥12 weeks at screening;
Patients with hematologic diseases, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia (ITP), myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes;
Patients who experienced thrombocytopenia within 6 months prior to screening due to non-cancer treatments, including but not limited to EDTA-dependent pseudo-thrombocytopenia, hypersplenism, infection, or bleeding.
Patients with brain tumors, brain metastases, bone marrow invasion, or bone marrow metastases;
Patients with hemoglobin <50 g/L after red blood cell transfusion or erythropoietin (EPO) treatment, or absolute neutrophil count <1.0×10⁹/L after granulocyte colony-stimulating factor (G-CSF) treatment;
Parallel
Romiplostim N01
DrugRomiplostim N01: 3-10 μg/kg(Initial dose 3 μ g/kg), qw, H.
Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks
Proportion of patients achieving ≥50×10⁹/L increase in PLT from baseline within 4 weeks
Time to first PLT recovery ≥100×10⁹/L
Proportion of patients requiring platelet transfusions due to thrombocytopenia
Frequency of PLT counts <75×10⁹/L during the study period
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This trial is not recruiting at the moment. You can still explore other options:
