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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Interleukin-11 | Drug | Human Interleukin-11 for Injection (rhlL-11) 25 - 50 μg/kg, subcutaneous injection, once a day, for at least 7 - 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The assessment will be conducted 31 months after the start of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The median time for platelet count to recover to ≥ 100 × 10^9/L | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Wang | Contact | 13931182128 | wangjunzr@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
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| Romiplostim N01 | Drug | 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 |
|
| 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. | 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 | 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. | The assessment will be conducted 40 months after the start of the treatment. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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