Overview

Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Huazhong University of Science and Technology
Criteria
Inclusion Criteria:

1. Volunteer to participate in clinical research and sign informed consent;

2. Age ≥18 years;

3. Digestive system malignancy confirmed by histology or cytology; Having used
oxaliplatin combined with fluorouracil for at least one cycle of 21-day chemotherapy
regimen (CAPOX or SOX regimen), platelet index after chemotherapy: ≥25×109/L and
≤75×109/L;

4. At least 10 days between TPO, IL-11 or platelet transfusion;

5. ECOG 0 to 2 points;

6. Expected survival time > 3 months;

7. Sufficient organ function for subsequent chemotherapy;

8. Women of reproductive age must be willing to use adequate contraception during the
study of drug treatment.

Exclusion Criteria:

1. Thrombocytopenia caused by non-tumor chemotherapy drugs occurred within 6 months
before screening, including but not limited to EDTA-dependent pseudothrombocytopenia,
hypersplenism, infection, and bleeding;

2. Have any hematological malignancies, including leukemia, myeloma, bone marrow
proliferative diseases, lymphoma or bone marrow proliferative diseases;

3. Clinically significant acute or active bleeding within the week prior to screening;

4. Subject has medically known hereditary prethrombotic syndrome (e.g., factor V Leiden
mutation, prothrombin G20210A mutation, or hereditary antithrombin III (ATIII)
deficiency)

5. The subject has a history of major cardiovascular disease (e.g., congestive heart
failure (New York Heart Association Class 3/ cardiac function), known arrhythmias
(e.g., atrial fibrillation) that increase the risk of thromboembolic events, coronary
stenting, angioplasty, or coronary artery bypass grafting);

6. Subjects had a history of arterial or venous thrombosis within 3 months before
screening;

7. Use of a vitamin K antagonist (including low molecular weight heparin, factor Xa
inhibitor, or thrombin inhibitor) within 7 days prior to screening;

8. The subject has a history of chronic platelet or hemorrhagic disorders, or
thrombocytopenia from causes other than CIT (e.g., chronic liver disease or immune
thrombocytopenic purpura);

9. TPO, IL-11 or platelet infusion were used within 10 days before enrollment;

10. Previous use of thrombopoietin receptor agonists (e.g., eltrobopag, romiestine, etc.)

11. Those who cannot be treated with oral drugs;

12. Allergic to hetrombopag or any excipient;

13. Those whose organ function could not tolerate further antitumor therapy as assessed by
the investigator; This product is not recommended for use or discontinuation of
treatment in patients who meet any of the following criteria for liver function

ALT and AST > 8 x ULN.

ALT or AST>5×ULN for 2 weeks;

ALT or AST>3xULN (total bilirubin >2xULN or INR>1.5);

ALT or AST>3×ULN with progressive fatigue, nausea, vomiting, right upper abdominal pain or
tenderness, fever, rash, and/or eosinophilia (>5%).