NCT07128576尚未招募2 期
A Multicenter Phase II Clinical Study of Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors
Zhujiang Hospital0 个研究点目标入组 60 人开始时间: 2025年9月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •ECOG score 0, 1, or 2;
- •Premenopausal women/men of childbearing potential must agree to contraceptive measures during and for 6 months post-study; non-lactating patients;
- •No participation in other drug clinical trials within 4 weeks prior to enrollment;
- •Voluntary signing of informed consent after full comprehension of study requirements.
排除标准
- •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;
- •Patients who experienced any arterial or venous thrombosis within 6 months prior to screening;
- •Patients with severe cardiovascular diseases within 6 months prior to screening (e.g., NYHA Class III-IV heart failure), high-risk arrhythmias (e.g., atrial fibrillation), coronary stent placement, angioplasty, or coronary artery bypass grafting;
- •Patients who received platelet transfusion within 5 days prior to enrollment;
- •Patients who received thrombopoietin receptor agonist treatment within 4 weeks prior to study drug administration, recombinant human thrombopoietin (rhTPO) or rhIL-11 within 4 weeks prior to enrollment, or other platelet-enhancing traditional Chinese medicine within 1 week prior to enrollment;
- •Patients with positive hepatitis C antibody and detectable HCV-RNA, positive hepatitis B surface antigen and detectable HBV-DNA, severe cirrhosis, HIV antibody positivity, or syphilis antibody positivity;
- •Patients with ALT and AST ≥3×ULN (for subjects without liver metastasis) or ≥5×ULN (for subjects with liver metastasis) during screening;
- •Patients with serum creatinine ≥1.5×ULN or estimated glomerular filtration rate (eGFR) ≤60 mL/min;
- •Patients with known allergies or intolerances to the active ingredients or excipients of romiplostim N01 for injection;
- •Patients who are pregnant, planning pregnancy, or breastfeeding;
- •Patients deemed unsuitable for participation in the trial by the investigator.
研究组 & 干预措施
arm A: PLT 10-50×10^9/L romiplostim N01
Experimental
干预措施: Romiplostim N01 (Drug)
arm B: PLT 50-70×10^9/L romiplostim N01
Experimental
干预措施: Romiplostim N01 (Drug)
结局指标
主要结局
Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks
时间窗: 2 weeks
次要结局
- Proportion of patients requiring platelet transfusions due to thrombocytopenia(1 month)
- Incidence of severe adverse events (SAEs) graded by CTCAE v5.0 criteria(2 months)
- Proportion of patients achieving ≥50×10⁹/L increase in PLT from baseline within 4 weeks(4 weeks)
- Frequency of PLT counts <75×10⁹/L during the study period(1 month)
- Incidence of dose modifications, delays, or discontinuations caused by thrombocytopenia(1 month)
- Time to first PLT recovery ≥100×10⁹/L(1 month)
研究者
bujunguo
Doctor
Zhujiang Hospital
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