Solid TumorsPhase 2NCT07128576
Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors
A Phase 2 study testing Romiplostim N01 in people with Solid Tumors, run by Zhujiang Hospital.
Trial summary
With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice. Beyond conventional chemotherapy combination regimens, the integration of radiotherapy into multimodal treatment strategies has also expanded significantly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Romiplostim N01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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;
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: A Multicenter Phase II Clinical Study of Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors
With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice. Beyond conventional chemotherapy combination regimens, the integration of radiotherapy into multimodal treatment strategies has also expanded significantly.
While robust evidence supports the use of romiplostim for managing chemotherapy-induced thrombocytopenia (CIT), there is currently no clinical research evaluating its efficacy in treating thrombocytopenia associated with radiotherapy-combined treatment regimens in solid tumors.
To address this unmet clinical need, this study aims to evaluate the safety and efficacy of romiplostim N01 for injection in the treatment of radiotherapy-combined regimen-induced thrombocytopenia in solid tumor patients. The findings will establish evidence-based management strategies to optimize clinical decision-making in this context.
- Conditions
- Solid Tumors
- Being tested
- Romiplostim N01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Romiplostim N01Drug
Romiplostim N01: 3-10 μg/kg(Initial dose 3 μ g/kg), qw, H.
| Study group | Role | What they receive |
|---|---|---|
| arm A: PLT 10-50×10^9/L romiplostim N01 | Experimental | Not described Receives: Drug: Romiplostim N01 |
| arm B: PLT 50-70×10^9/L romiplostim N01 | Experimental | Not described Receives: Drug: Romiplostim N01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks
Measured: 2 weeks
Secondary outcomes (6)
Proportion of patients achieving ≥50×10⁹/L increase in PLT from baseline within 4 weeks
Measured: 4 weeks
Time to first PLT recovery ≥100×10⁹/L
Measured: 1 month
Proportion of patients requiring platelet transfusions due to thrombocytopenia
Measured: 1 month
Frequency of PLT counts <75×10⁹/L during the study period
Measured: 1 month
Incidence of dose modifications, delays, or discontinuations caused by thrombocytopenia
Measured: 1 month
Incidence of severe adverse events (SAEs) graded by CTCAE v5.0 criteria
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bujunguo, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128576
- Sponsor's protocol ID
- 2025-KY-078-01
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Clinical Study of Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07128576
- Acronym / sponsor ID
- 2025-KY-078-01
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice. Beyond conventional chemotherapy combination regimens, the integration of radiotherapy into multimodal treatment strategies has also expanded significantly.
While robust evidence supports the use of romiplostim for managing chemotherapy-induced thrombocytopenia (CIT), there is currently no clinical research evaluating its efficacy in treating thrombocytopenia associated with radiotherapy-combined treatment regimens in solid tumors.
To address this unmet clinical need, this study aims to evaluate the safety and efficacy of romiplostim N01 for injection in the treatment of radiotherapy-combined regimen-induced thrombocytopenia in solid tumor patients. The findings will establish evidence-based management strategies to optimize clinical decision-making in this context.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm A: PLT 10-50×10^9/L romiplostim N01 | Experimental | Drug: Romiplostim N01 |
| arm B: PLT 50-70×10^9/L romiplostim N01 | Experimental | Drug: Romiplostim N01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Romiplostim N01Romiplostim N01: 3-10 μg/kg(Initial dose 3 μ g/kg), qw, H. | Drug | arm A: PLT 10-50×10^9/L romiplostim N01, arm B: PLT 50-70×10^9/L romiplostim N01 |
Primary outcome
Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks
Time frame: 2 weeks
6 secondary outcomes
Proportion of patients achieving ≥50×10⁹/L increase in PLT from baseline within 4 weeks
Time frame: 4 weeks
Time to first PLT recovery ≥100×10⁹/L
Time frame: 1 month
Proportion of patients requiring platelet transfusions due to thrombocytopenia
Time frame: 1 month
Frequency of PLT counts <75×10⁹/L during the study period
Time frame: 1 month
Incidence of dose modifications, delays, or discontinuations caused by thrombocytopenia
Time frame: 1 month
Incidence of severe adverse events (SAEs) graded by CTCAE v5.0 criteria
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Romiplostim N01 in people with Solid Tumors, run by Zhujiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving ≥50×10⁹/L increase in platelet count (PLT) from baseline within 2 weeks (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.