Status:
NOT_YET_RECRUITING
A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors
Lead Sponsor:
Jun wang
Conditions:
Solid Tumor Malignancies, Cancer
CTIT-Chemotherapy Induced Thrombocytopenia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of Romiplostim N01 in patients with solid tumors who are undergoing concurrent/sequential radiotherapy and chemotherapy（combin...
Eligibility Criteria
Inclusion
- Age:18 to 80 years old (man or female);
- Confirmed with solid tumor by pathological histology or cytology examination;
- The patient is undergoing concurrent/sequential radiotherapy ± immunotherapy;
- During the treatment period, the patient experienced a decrease in platelets, and the platelet count within the last 3 days before enrollment was 25×10\^9/L \< platelet count ≤ 75×10\^9/L;
- The estimated survival period at screening is ≥ 3 months, and it is expected that the current chemotherapy cycle can be used for ≥ 2 cycles;
- ECOG 0 - 2;
- Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
Exclusion
- Platelet count ≤ 25×10\^9/L at baseline;
- The patient has previously received treatments for thrombocytopenia, such as thrombopoietin receptor agonists (TOP-RA), recombinant human thrombopoietin (rhTPO), or rhIL-11, etc.;
- Patients with hematological disorders, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia, myelodysplastic syndromes, multiple myeloma, and myelodysplastic syndrome, etc.;
- Have experienced thrombocytopenia due to non-tumor treatment within the past 6 months, including but not limited to EDTA-dependent pseudo-thrombocytopenia, splenomegaly, infection, bleeding, etc.;
- After red blood cell or erythropoietin (EPO) infusion, hemoglobin is still \< 50g/L, or after granulocyte colony-stimulating factor (G-CSF) treatment, absolute neutrophil count is still \< 1.0×10\^9/L;
- Have experienced any arterial or venous thrombosis within the past 6 months;
- Have suffered from severe cardiovascular diseases (such as NYHA cardiac function class III-IV), increased risk of thrombosis-related arrhythmias (such as atrial fibrillation), coronary artery stent implantation, angioplasty, and coronary artery bypass grafting within the past 6 months;
- Have received platelet transfusion within 5 days before randomization or enrollment;
- Patients with positive hepatitis C antibody and excessive HCV-RNA detection, positive hepatitis B surface antigen and excessive HBV-DNA detection, patients with severe cirrhosis, positive HIV antibody, or positive syphilis antibody;
- During screening, for subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≥ 3 times ULN; for subjects with liver metastasis, ≥ 5 times ULN;
- Serum creatinine concentration ≥ 1.5 times ULN or eGFR ≤ 60ml/min;
- Patients who are allergic or intolerant to the active ingredient or excipients of Romiplostim N01 for injection;
- Planning to get pregnant or in the lactation period;
- The investigator determines that the patient is not suitable to participate in this trial.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT07185893
Start Date
September 1 2025
End Date
December 31 2028
Last Update
September 22 2025
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China