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To observe the clinical efficacy and safety of avatrombopag for chemotherapy-induced thrombocytopenia in patients with malignant tumors.
Tumor is one of the malignant diseases that people face. In 2015, the incidence of malignant tumors was about 3.929 million, and the annual growth rate is about 3.9%. Chemotherapy is currently the most commonly used treatment for patients with tumor, but chemotherapy also brings many other problems, such as thrombocytopenia which can leads to increased medical costs, chemotherapy cycles delayed, and chemotherapy doses reduced. Studies have found that the reduction of the chemotherapy dose and the delay of the chemotherapy cycle will affect the survival rate of patients. So it is an important to solve the problem of chemotherapy-induced thrombocytopenia.
Currently, there are some methods to treat thrombocytopenia such as platelet transfusion, rhTPO, rhIL-11 and other methods. However, these methods have some defects, platelets are at risk of ineffective transfusion, rhTPO may produce neutralizing antibodies and rhIL-11 has serious side effects. Therefore, there is an urgent need for safer and faster methods to treat chemotherapy-induced thrombocytopenia. As a new generation of TPO receptor agonist, avatrombopag has the advantages of being taken with food, no hepatotoxicity, good safety, and rapidly increase platelet count. Therefore, avatrombopag has great research value in the treatment of chemotherapy-induced thrombocytopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avatrombopag Tablets Oral | Experimental | When patient is diagnosed with thrombocytopenia induced by chemotherapy of malignant tumor, avatrombopag will be given to patients as a therapeutic plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | 10×109/L\ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders | Proportion of patients with platelet count ≥100×10^9/L or increase of platelet count ≥50×10^9/L or ≥100% from baseline within cycle X after initiation of avatrombopag treatment.Due to chemotherapy induced thrombocytopenia in the X+1 cycle, the dose reduction in chemotherapy of X+2 cycle by ≥15% or chemotherapy delay by ≥4 days. | up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of grade â…¢ and â…£ thrombocytopenia after initiation of avatrombopag treatment | up to 2 months | |
| Time for PLT to recover to ≥75×10^9/L and ≥100×10^9/L after initiation of avatrombopag treatment | up to 2 months |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | 230000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36238568 | Derived | Cui Y, He Y, Hu C, Tu C, Huang J, Zhu X, Zang C, Ding K, Zhan B, Zhao Y, Qian L. Avatrombopag for the treatment of thrombocytopenia induced by chemotherapy in patients with solid tumors: A multicenter, open-label, single-arm trial. Front Pharmacol. 2022 Sep 27;13:970978. doi: 10.3389/fphar.2022.970978. eCollection 2022. |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C533238 | avatrombopag |
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| minimal platelet count | up to 2 months |
| Proportion of patients without platelet transfusion | up to 2 months |
| Proportion of patients without bleeding | up to 2 months |