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

What Was Tested

This registered not phased trial tested Romiplostim.

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.

It had two arms (groups): Romiplostim N01 (experimental) and Human Interleukin-11 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 106 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;. 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;.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: 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.;.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-09 with completion listed for 2028-03-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The proportion of patients who achieved a response within 14 days of treatment (time frame: The assessment will be conducted 31 months after the start of the treatment).

It also tracked 5 secondary outcomes, for example 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 and Incidence rate of adverse events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Romiplostim in 106 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.