A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia

Study Overview
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Brief Summary
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The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia

Detailed Description
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CIT is one of the most common complications of tumor treatment, which is caused by the inhibition of anticancer chemotherapy drugs on megakaryocytes in bone marrow, resulting in platelet count lower than 100×109/L in peripheral blood, and is a common hematological toxic reaction in clinic. CIT leads to an increased risk of bleeding and transfusion, and severe CIT can cause intracranial bleeding and death. The use of platelet infusion is limited and ineffective in 25% of patients. rhIL-11 increases the incidence of cardiovascular events and rhTPO may produce immunogenicity. Currently, TPO-RA is recommended for the treatment of CIT by consensus guidelines at home and abroad. The study was designed to explore the safety and efficacy of Herombopag in the treatment of tumour-associated thrombocytopenia.

Official Title
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A Prospective, Multi-cohort, Open-label Clinical Study of the Efficacy and Safety of Herombopag in Tumors-associated Thrombocytopenia

Conditions
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Tumor Therapy-related Thrombocytopenia

Intervention / Treatment
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* Drug: TPO-RA (Herombopag)
* Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18, no gender limitation; Participants with solid tumors confirmed by histopathological or cytological examination; During the current tumor treatment cycle, the participants whose PLT<50×109/L, and will receive the current tumor treatment regimen for at least 1 cycle; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Voluntarily participated in the study and signed the informed consent with good compliance. Exclusion Criteria: Suffering from any of the following diseases of the hematopoietic system other than thrombocytopenia caused by tumor therapy, including but not limited to leukemia, primary immune thrombocytopenia, myeloid proliferative disease, multiple myeloma and myelodysplastic syndrome; Suffering from thrombocytopenia (not caused by tumor treatment), including but not limited to chronic liver disease, hypersplenism, infection, and bleeding, within 6 months prior to screening; Bone marrow invasion or bone marrow metastasis; Received radiation therapy to the pelvis, spine and bone field within 3 months prior to screening; or is/is expected to receive radiation therapy. Received TPO-RA drugs (such as altrepopal and romistine), or rhTPO or rhIL-11 in the current cancer treatment cycle; Received platelet transfusion within 3 days prior to randomization; Participants with known or expected allergy or intolerance to the active ingredient or excipient of Herombopag Olamine tablets; Pregnant or lactating women; Participants who are participating in other clinical trials. Other conditions that the investigator determines are not suitable for inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Herombopag monotherapy<br> | Drug: TPO-RA (Herombopag)<br>* During the correction period, subjects will receive a dose of Herombopag starting at 5-7.5mg once daily, orally for 14 days, subject to dosing adjustment (or discontinuation) depending on their platelet response or at the investigator's discretion. In the secondary prophylaxis phase, Herombopag 5mg once daily, starting 5 days before antineoplastic therapy and continuing for 10-14 days.<br>|
| Experimental: Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)<br> | Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)<br>* During the correction period, subjects will receive a combination of Herombopag and rhTPO, Herombopag starting at a recommended dose of 5mg once daily for 14 days. The recombinant human thrombopoietin dose is 300U/kg. bw/day or 15000U/day per person, once daily, for 14 consecutive days (or as determined by the investigator). In the secondary prophylaxis phase, Herombopag 5mg once daily, starting 5 days before antineoplastic therapy and continuing for 10-14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During the correction period, the percentage of patients whose platelets returned to normal within 14 days | Percentage of patients whose platelets returned to normal within 14 days | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During the correction period, the median time for platelet values to return to normal | Median time for platelet values to return to normal | up to 60 days | 
| During the correction period, the Median time for platelet count to return to 75×109/L | Median time for platelet count to return to 75×109/L | up to 60 days | 
| During the correction period, the median time for platelet count to return to 50×109/L | Median time for platelet count to return to 50×109/L | up to 60 days | 
| During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days | Percentage of patients whose platelets returned to75×109/L within 14 days | up to 14 days | 
| During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days | Percentage of patients whose platelets returned to 50×109/L within 14 days | up to 14 days | 
| During the correction period, platelet infusion rate after initiation of Herombopag therapy. | During the correction period, platelet infusion rate after initiation of Herombopag therapy. | up to 14 days | 
| During the prophylaxis period, the proportion of patients whose PLT<75×109/L | During the prophylaxis period, the proportion of patients whose PLT<75×109/L | up to 14 days | 
| During the prophylaxis period, the proportion of patients whose PLT<50×109/L | During the prophylaxis period, the proportion of patients whose PLT<50×109/L | up to 14 days | 
| During the prophylaxis period, platelet counts are at their lowest. | During the prophylaxis period, platelet counts are at their lowest. | up to 14 days | 
| During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy. | During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy. | up to 14 days | 
| Platelet value curve | Platelet value curve | up to 60 days |