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This study was an open-label, controlled, single-center, prospective phase II trial. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT,PLT:<50*10^9/L). Both groups received rhTPO and Hetrombopag treatment. A target sample size of 100 participants will be observed to characterize the clinical features and treatment patterns of cancer therapy-induced thrombocytopenia. Recombinant human thrombopoietin (rhTPO) and hetrombopag will be administered until a platelet count ≥ 75 × 10⁹/L is achieved. Beyond the protocol-specified dual therapy, basic management, including supportive care or concomitant medications-will remain at the investigator's discretion.
This research will gather real-world data on an investigational drug in a prospective manner, aiming to monitor 100 patients to explore the characteristics and treatment approaches of thrombocytopenia associated with tumor therapy. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT,PLT:<50*10^9/L).
Patients with platelet counts between 50×10^9/L and 75×10^9/L will be randomly allocated to either Arm A or Arm B. In Arm A and Arm B, participants will receive standard care, which may include medications such as interleukin-11, leucogen, and yixuesheng. Meanwhile, individuals in Arm B will be administered recombinant human thrombopoietin (rhTPO) and eltrombopag until their platelet count reaches or exceeds 75×10^9/L.
This study will prospectively gather relevant patient information. Data collection will occur over two tumor treatment cycles and during the administration of thrombopoietin-promoting drugs for all participants. Specifically, the following data will be collected for each patient across two consecutive chemotherapy cycles (Cycle N and Cycle N+1):
The aim is to comprehensively document these aspects to ensure thorough analysis and evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | For ctit patients with platelet counts ≥50×109/L and <75×109/L, they were randomized into groups A. |
| |
| Group B | For ctit patients with platelet counts <50×109/L, they were randomized into groups B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTPO | Drug | In group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. |
| Measure | Description | Time Frame |
|---|---|---|
| Time for platelets to rise from nadir to 75 x 109/L | Time for platelets to rise from nadir to 75 x 109/L | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The time required for platelet count to rise to 100×10⁹/L, the proportion of patients with a delay of ≥7 days in the next cycle, bleeding, receiving platelet transfusion and treatment-related adverse reactions. | The time required for platelet count to rise to 100×10⁹/L, the proportion of patients with a delay of ≥7 days in the next cycle, bleeding, receiving platelet transfusion and treatment-related adverse reactions. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with tumor therapy-related thrombocytopenia treated with thrombopoietic agents
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| Name | Affiliation | Role |
|---|---|---|
| Jianfei Fu, PhD | Director of Medical Oncology Department of Jinhua Municipal Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Central Hospital | Jinhua | Zhejiang | 321000 | China |
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Information about patients will be collected prospectively in this study, which will collect information about all enrolled patients' two tumor treatment cycles and prothrombogenic drug therapy during them. The data to be collected will include the patient's baseline characteristics, the dose, frequency, and duration of each study drug, the name, dose, frequency, and duration of any combinations of study drugs, laboratory tests (e.g., blood counts) before, during, and after treatment with each study drug, and records of adverse events, including those related to the patients' baseline characteristics. and other relevant content.
| hypertrombopa | Drug | In group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. |
|
| up to 4 weeks |