New hope for cancer patients: drug may fix Radiation-Related low platelets
NCT ID NCT07128576
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether romiplostim N01 can safely raise low platelet counts in 60 adults with solid tumors who have had radiotherapy combined with other treatments. The main goal is to see if platelet counts increase by at least 50 billion per liter within two weeks. The study is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Romiplostim N01 (a drug that stimulates platelet production)
- What this could lead to
- If it works, this could provide a new option to manage low platelets in cancer patients receiving radiotherapy combinations, reducing the need for transfusions.
- What could go wrong
- This is an early phase 2 trial with only 60 participants, so results may not apply broadly. The drug may not work as hoped or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * Premenopausal women/men of childbearing potential must agree to contraceptive measures during and for 6 months post-study; non-lactating patients; * No participation in other drug clinical trials within 4 weeks prior to enrollment; * Voluntary signing of informed consent after full comprehension of study requirements. Exclusion Criteria: * 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; * Patients with hemoglobin \<50 g/L after red blood cell transfusion or erythropoietin (EPO) treatment, or absolute neutrophil count \<1.0×10⁹/L after granulocyte colony-stimulating factor (G-CSF) treatment; * Patients who experienced any arterial or venous thrombosis within 6 months prior to screening; * Patients with severe cardiovascular diseases within 6 months prior to screening (e.g., NYHA Class III-IV heart failure), high-risk arrhythmias (e.g., atrial fibrillation), coronary stent placement, angioplasty, or coronary artery bypass grafting; * Patients who received platelet transfusion within 5 days prior to enrollment; * Patients who received thrombopoietin receptor agonist treatment within 4 weeks prior to study drug administration, recombinant human thrombopoietin (rhTPO) or rhIL-11 within 4 weeks prior to enrollment, or other platelet-enhancing traditional Chinese medicine within 1 week prior to enrollment; * Patients with positive hepatitis C antibody and detectable HCV-RNA, positive hepatitis B surface antigen and detectable HBV-DNA, severe cirrhosis, HIV antibody positivity, or syphilis antibody positivity; * Patients with ALT and AST ≥3×ULN (for subjects without liver metastasis) or ≥5×ULN (for subjects with liver metastasis) during screening; * Patients with serum creatinine ≥1.5×ULN or estimated glomerular filtration rate (eGFR) ≤60 mL/min; * Patients with known allergies or intolerances to the active ingredients or excipients of romiplostim N01 for injection; * Patients who are pregnant, planning pregnancy, or breastfeeding; * Patients deemed unsuitable for participation in the trial by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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