Clinical Trial

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

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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(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.
Trial Details
NCT Number NCT07185893
Lead Sponsor Jun wang
Conditions Solid Tumor Malignancies, Cancer, CTIT-Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
Enrollment 106 participants
Start Date 2025-09
Primary Completion 2028-03-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-22