Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors

NCT07128576 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-KY-078-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks

  2 weeks

Secondary Outcomes (6)

• Proportion of patients achieving ≥50×10⁹/L increase in PLT from baseline within 4 weeks

  4 weeks

• Time to first PLT recovery ≥100×10⁹/L

  1 month

• Proportion of patients requiring platelet transfusions due to thrombocytopenia

  1 month

• 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

Study Arms (2)

arm A: PLT 10-50×10^9/L romiplostim N01

EXPERIMENTAL

Drug: Romiplostim N01

arm B: PLT 50-70×10^9/L romiplostim N01

EXPERIMENTAL

Drug: Romiplostim N01

Interventions

Romiplostim N01 DRUG

Romiplostim N01: 3-10 μg/kg(Initial dose 3 μ g/kg), qw, H.

arm A: PLT 10-50×10^9/L romiplostim N01; arm B: PLT 50-70×10^9/L romiplostim N01

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08