Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors

What Was Tested

This registered phase 2 trial tested Romiplostim.

With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice.

It had two arms (groups): arm A: PLT 10-50×10^9/L romiplostim N01 (experimental) and arm B: PLT 50-70×10^9/L romiplostim N01 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥18 years, regardless of gender; Histopathologically confirmed solid tumor patients (including but not limited to nasopharyngeal carcinoma, lung cancer, breast cancer, etc.);. Prior radiotherapy (RT) ≥45Gy (including standalone RT, concurrent/sequential chemoradiotherapy, or RT combined with other antitumor therapies, with treatment duration ≥2 weeks), regardless of prior induction/adjuvant chemotherapy;. Platelet count \<75×10⁹/L within 3 days prior to enrollment, occurring during RT or within 1 month post-RT;. Estimated survival ≥12 weeks at screening;. ECOG score 0, 1, or 2;.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: patients with hematologic diseases, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia (itp), myeloproliferative disorders, multiple myeloma, or myelodysplastic syndromes;; patients who experienced thrombocytopenia within 6 months prior to screening due to non-cancer treatments, including but not limited to edta-dependent pseudo-thrombocytopenia, hypersplenism, infection, or bleeding; patients with brain tumors, brain metastases, bone marrow invasion, or bone marrow metastases;.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

Being open-label, the Romiplostim study did not mask who received what.

It started in 2025-09-15 with completion listed for 2027-08-15.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 6 secondary outcomes, for example Time to first PLT recovery ≥100×10⁹/L, Proportion of patients requiring platelet transfusions due to thrombocytopenia, Frequency of PLT counts <75×10⁹/L during the study period and Incidence of severe adverse events (SAEs) graded by CTCAE v5.0 criteria.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Romiplostim in 60 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.