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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| herombopag olamine tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| herombopag olamine tablets | Drug | The first day of chemotherapy was d1, and the drug was started from d-5, 5 days before chemotherapy, with oral herombopag 5 mg/day for a maximum of 14 days. After chemotherapy, when the thrombocytopenia rises to ≥200×109/L, drug discontinuation can be considered |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the response rate of hetrombopag | response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by >7 days. | Follow-up to 28 days after the last use of herombopag |
| Measure | Description | Time Frame |
|---|---|---|
| The lowest platelet value after chemotherapy | The lowest platelet value after chemotherapy | Follow-up to 28 days after the last use of herombopag |
| Platelet recovery to the highest value after chemotherapy; |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of platelet value in each visit cycle | Changes of platelet value in each visit cycle | Follow-up to 28 days after the last use of herombopag |
Inclusion Criteria:
1) Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 7. Life expectancy at screening ≥12 weeks; 8. ECOG: 0-1; 9. The main organ functions are normal, and there are no serious complications;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| qiming wang | Contact | 13783590691 | qimingwang1006@126.com | |
| zhen he | Contact | 13523530961 | 13523530961@163.com |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Platelet recovery to the highest value after chemotherapy;
| Follow-up to 28 days after the last use of herombopag |
| The duration of platelets ≤50×109/L; | The duration of platelets ≤50×109/L; | Follow-up to 28 days after the last use of herombopag |
| The time for platelets to recover to more than 100×109/L; | The time for platelets to recover to more than 100×109/L; | Follow-up to 28 days after the last use of herombopag |
| Incidence of adverse events | Incidence of adverse events | Follow-up to 28 days after the last use of herombopag |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |