Solid Tumor Malignancies, CancerNCT07185893
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
A study testing Human Interleukin-11 and Romiplostim N01 in people with Solid Tumor Malignancies, Cancer and CTIT-Chemotherapy Induced Thrombocytopenia, run by Jun wang at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the safety and efficacy of Romiplostim N01 in patients with solid tumors who are undergoing concurrent/sequential radiotherapy and chemotherapy（combined with/without immunotherapy）-related thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor Malignancies, Cancer, CTIT-Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
- What is being tested?
- Human Interleukin-11 and Romiplostim N01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to 31 Dec 2028
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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;
- 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;
- 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;
- Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
Who cannot join
- 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.;
- 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.;
- 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;
- Have experienced any arterial or venous thrombosis within the past 6 months;
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- 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;
- Have received platelet transfusion within 5 days before randomization or enrollment;
- 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;
- 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;
- Serum creatinine concentration ≥ 1.5 times ULN or eGFR ≤ 60ml/min;
- Patients who are allergic or intolerant to the active ingredient or excipients of Romiplostim N01 for injection;
- Planning to get pregnant or in the lactation period;
- The investigator determines that the patient is not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Jun Wang, 13931182128, wangjunzr@163.com
About this study
The purpose of this clinical trial is to evaluate the safety and efficacy of Romiplostim N01 in patients with solid tumors who are undergoing concurrent/sequential radiotherapy and chemotherapy（combined with/without immunotherapy）-related thrombocytopenia.
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. The proportion of patients who received platelet transfusion due to thrombocytopenia during the treatment process, as well as the adjustment, delay and discontinuation of radiotherapy and chemotherapy doses； 2. Can patients treated with Romiplostim N01 restore their platelet count to ≥ 100×10^9/L and what is the response rate of patients during the treatment (response criteria: no need for platelet transfusion and PLT increase ≥ 50×10^9/L or at least twice the baseline or PLT increase to ≥ 100×10^9/L)；3. The safety and tolerance of Romiplostim N01 in treating CTIT.
- Conditions
- Solid Tumor Malignancies, Cancer, CTIT-Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
- Being tested
- Human Interleukin-11, Romiplostim N01
- Keywords
- Romiplostim N01, Human Interleukin-11, solid tumor, thrombocytopenia, CTIT
- Medical subject headings
- Neoplasms, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Interleukin-11Drug
Human Interleukin-11 for Injection (rhlL-11) 25 - 50 μg/kg, subcutaneous injection, once a day, for at least 7 - 10 days.
Romiplostim N01Drug
Administer Romiplostim N01 subcutaneously in the abdominal area. The initial dose is 3 μg/kg, once a week. The subsequent dose will be adjusted according to the patient's platelet count
| Study group | Role | What they receive |
|---|---|---|
| Romiplostim N01 | Experimental | Administer Romiplostim N01 subcutaneously in the abdominal area. The initial dose is 3 μg/kg, once a week. The subsequent dose will be adjusted according to the patient's platelet count Receives: Drug: Romiplostim N01 |
| Human Interleukin-11 | Active comparator | Human Interleukin-11 for Injection (rhlL-11) 25 - 50 μg/kg, subcutaneous injection, once a day, for at least 7 - 10 days. Receives: Drug: Human Interleukin-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieved a response within 14 days of treatment
Response criteria: no need for platelet transfusion and PLT increase ≥ 50×10^9/L or at least twice the baseline level or PLT increase to ≥ 100×10^9/L.
Measured: The assessment will be conducted 31 months after the start of the treatment.
Secondary outcomes (5)
The median time for platelet count to recover to ≥ 100 × 10^9/L
Measured: The assessment will be conducted 31 months after the start of the treatment.
The proportion of patients who received platelet transfusions during the treatment stage due to thrombocytopenia
Measured: The assessment will be conducted 31 months after the start of the treatment.
The proportion of patients who achieved a response within 3 days, 7 days, and 10 days of treatment
Response criteria: no need for platelet transfusion and PLT increase ≥ 50×10^9/L or at least twice the baseline level or PLT increase to ≥ 100×10^9/L.
Measured: The assessment will be conducted 31 months after the start of the treatment.
The incidence of dose adjustment, delay, or termination of radiotherapy and chemotherapy due to thrombocytopenia
Measured: The assessment will be conducted 31 months after the start of the treatment.
Incidence rate of adverse events
The adverse events of the Romiplostim N01 and Human Interleukin-11 will be evaluated, Including the incidence of all adverse events, grade 3/4 adverse events, the incidence of adverse events leading to treatment discontinuation, leading to death, SAEs, as well as the duration of adverse events, management measures and outcomes.
Measured: The assessment will be conducted 40 months after the start of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startSep 2025 (estimated)
- Primary completion1 Mar 2028 (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 Tumor Malignancies, CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jun wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jun wang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185893
- Sponsor's protocol ID
- 2025KY020
- Status last verified
- Aug 2025
- First submitted
- 15 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07185893
- Acronym / sponsor ID
- 2025KY020
- Conditions
- Solid Tumor Malignancies, Cancer, CTIT-Chemotherapy Induced Thrombocytopenia, Thrombocytopenia
- Keywords
- Romiplostim N01, Human Interleukin-11, solid tumor, thrombocytopenia, CTIT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Jun wangUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Sep 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.
The purpose of this clinical trial is to evaluate the safety and efficacy of Romiplostim N01 in patients with solid tumors who are undergoing concurrent/sequential radiotherapy and chemotherapy（combined with/without immunotherapy）-related thrombocytopenia.
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. The proportion of patients who received platelet transfusion due to thrombocytopenia during the treatment process, as well as the adjustment, delay and discontinuation of radiotherapy and chemotherapy doses； 2. Can patients treated with Romiplostim N01 restore their platelet count to ≥ 100×10^9/L and what is the response rate of patients during the treatment (response criteria: no need for platelet transfusion and PLT increase ≥ 50×10^9/L or at least twice the baseline or PLT increase to ≥ 100×10^9/L)；3. The safety and tolerance of Romiplostim N01 in treating CTIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim N01 | Experimental | Drug: Romiplostim N01Administer Romiplostim N01 subcutaneously in the abdominal area. The initial dose is 3 μg/kg, once a week. The subsequent dose will be adjusted according to the patient's platelet count |
| Human Interleukin-11 | Active comparator | Drug: Human Interleukin-11Human Interleukin-11 for Injection (rhlL-11) 25 - 50 μg/kg, subcutaneous injection, once a day, for at least 7 - 10 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- 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;
- The estimated survival period at screening is ≥ 3 months, and it is expected that the current chemotherapy cycle can be used for ≥ 2 cycles;
Key exclusion criteria (14 listed)
- 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.;
- 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.;
- 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;
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 |
|---|---|---|
| Human Interleukin-11Human Interleukin-11 for Injection (rhlL-11) 25 - 50 μg/kg, subcutaneous injection, once a day, for at least 7 - 10 days. | Drug | Human Interleukin-11 |
| Romiplostim N01Administer Romiplostim N01 subcutaneously in the abdominal area. The initial dose is 3 μg/kg, once a week. The subsequent dose will be adjusted according to the patient's platelet count | Drug | Romiplostim N01 |
Primary outcome
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.
Response criteria: no need for platelet transfusion and PLT increase ≥ 50×10^9/L or at least twice the baseline level or PLT increase to ≥ 100×10^9/L.
5 secondary outcomes
The median time for platelet count to recover to ≥ 100 × 10^9/L
Time frame: The assessment will be conducted 31 months after the start of the treatment.
The proportion of patients who received platelet transfusions during the treatment stage due to thrombocytopenia
Time frame: The assessment will be conducted 31 months after the start of the treatment.
The proportion of patients who achieved a response within 3 days, 7 days, and 10 days of treatment
Time frame: The assessment will be conducted 31 months after the start of the treatment.
The incidence of dose adjustment, delay, or termination of radiotherapy and chemotherapy due to thrombocytopenia
Time frame: The assessment will be conducted 31 months after the start of the treatment.
Incidence rate of adverse events
Time frame: The assessment will be conducted 40 months after the start of the treatment.
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 22 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human Interleukin-11 and Romiplostim N01 in people with Solid Tumor Malignancies, Cancer and CTIT-Chemotherapy Induced Thrombocytopenia, run by Jun wang at 1 site in China.
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 7 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 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Contact Jun Wang (13931182128, wangjunzr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 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 22 Sep 2025.