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（combined with/without immunotherapy）-related thrombocytopenia.
All eligible patients will be stratified and randomly assigned based on baseline platelet count（Stratification factors: whether the baseline platelet count of the patients is greater than 50×10\^9/L. ） . All patients will be randomly assigned in a 1:1 ratio to experimental group or control group:
Experimental group: Romiplostim N01 (N=53) Control group：Human Interleukin-11(rhlL-11) (N=53) The main questions this trial aims to answer are: 1. The proportion of patients who received platelet transfusion due to thrombocytopenia during the treatment process, as well as the adjustment, delay and discontinuation of radiotherapy and chemotherapy doses； 2. Can patients treated with Romiplostim N01 restore their platelet count to ≥ 100×10\^9/L and what is the response rate of patients during the treatment (response criteria: no need for platelet transfusion and PLT increase ≥ 50×10\^9/L or at least twice the baseline or PLT increase to ≥ 100×10\^9/L)；3. The safety and tolerance of Romiplostim N01 in treating CTIT.
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;
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.;
Parallel
Human Interleukin-11
DrugHuman Interleukin-11 for Injection (rhlL-11) 25 - 50 μg/kg, subcutaneous injection, once a day, for at least 7 - 10 days.
Romiplostim N01
DrugAdminister Romiplostim N01 subcutaneously in the abdominal area. The initial dose is 3 μg/kg, once a week. The subsequent dose will be adjusted according to the patient's platelet count
The proportion of patients who achieved a response within 14 days of treatment
Response criteria: no need for platelet transfusion and PLT increase ≥ 50×10\^9/L or at least twice the baseline level or PLT increase to ≥ 100×10\^9/L.
The median time for platelet count to recover to ≥ 100 × 10^9/L
The proportion of patients who received platelet transfusions during the treatment stage due to thrombocytopenia
The proportion of patients who achieved a response within 3 days, 7 days, and 10 days of treatment
Response criteria: no need for platelet transfusion and PLT increase ≥ 50×10\^9/L or at least twice the baseline level or PLT increase to ≥ 100×10\^9/L.
The incidence of dose adjustment, delay, or termination of radiotherapy and chemotherapy due to thrombocytopenia
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Jun wang
Lead sponsor
Hebei Medical University Fourth Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
