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

Inclusion criteria

• 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 criteria

• 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.