New drug aims to fix Chemo-Induced low platelets
NCT ID NCT07185893
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a drug called Romiplostim N01 in 106 cancer patients whose platelets drop due to chemo, radiation, or immunotherapy. The goal is to see if it can safely raise platelet counts better than the current standard treatment. Patients will be randomly assigned to receive either Romiplostim N01 or another drug (Interleukin-11) for up to 14 days.
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
- What this could lead to
- If it works, this could offer a new option to manage low platelets in cancer patients, reducing the need for platelet transfusions and treatment delays.
- What could go wrong
- This is an early-stage trial with only 106 participants, so results may not apply to all patients. The drug may not work better than existing treatments and could have 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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 106 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 to 80 years
- 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: 1. Age:18 to 80 years old (man or female); 2. Confirmed with solid tumor by pathological histology or cytology examination; 3. The patient is undergoing concurrent/sequential radiotherapy ± immunotherapy; 4. 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; 5. The estimated survival period at screening is ≥ 3 months, and it is expected that the current chemotherapy cycle can be used for ≥ 2 cycles; 6. ECOG 0 - 2; 7. Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form. Exclusion Criteria: 1. Platelet count ≤ 25×10\^9/L at baseline; 2. The patient has previously received treatments for thrombocytopenia, such as thrombopoietin receptor agonists (TOP-RA), recombinant human thrombopoietin (rhTPO), or rhIL-11, etc.; 3. Patients with hematological disorders, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia, myelodysplastic syndromes, multiple myeloma, and myelodysplastic syndrome, etc.; 4. 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.; 5. After red blood cell or erythropoietin (EPO) infusion, hemoglobin is still \< 50g/L, or after granulocyte colony-stimulating factor (G-CSF) treatment, absolute neutrophil count is still \< 1.0×10\^9/L; 6. Have experienced any arterial or venous thrombosis within the past 6 months; 7. Have suffered from severe cardiovascular diseases (such as NYHA cardiac function class III-IV), increased risk of thrombosis-related arrhythmias (such as atrial fibrillation), coronary artery stent implantation, angioplasty, and coronary artery bypass grafting within the past 6 months; 8. Have received platelet transfusion within 5 days before randomization or enrollment; 9. Patients with positive hepatitis C antibody and excessive HCV-RNA detection, positive hepatitis B surface antigen and excessive HBV-DNA detection, patients with severe cirrhosis, positive HIV antibody, or positive syphilis antibody; 10. During screening, for subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≥ 3 times ULN; for subjects with liver metastasis, ≥ 5 times ULN; 11. Serum creatinine concentration ≥ 1.5 times ULN or eGFR ≤ 60ml/min; 12. Patients who are allergic or intolerant to the active ingredient or excipients of Romiplostim N01 for injection; 13. Planning to get pregnant or in the lactation period; 14. The investigator determines that the patient is not suitable to participate in this trial.
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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 places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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