A Clinical Study of Herombopag in Tumors-associated Thrombocytopenia

Zhengzhou University

Status and phase: Unknown; Phase 2

Conditions: Tumor Therapy-related Thrombocytopenia

Treatments: Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin); Drug: TPO-RA (Herombopag)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05350956

HQBP-ZH-001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18, no gender limitation;
2. Participants with solid tumors confirmed by histopathological or cytological examination;
3. 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;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
5. Voluntarily participated in the study and signed the informed consent with good compliance.

Exclusion criteria

1. 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;
2. 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;
3. Bone marrow invasion or bone marrow metastasis;
4. Received radiation therapy to the pelvis, spine and bone field within 3 months prior to screening; or is/is expected to receive radiation therapy.
5. Received TPO-RA drugs (such as altrepopal and romistine), or rhTPO or rhIL-11 in the current cancer treatment cycle;
6. Received platelet transfusion within 3 days prior to randomization;
7. Participants with known or expected allergy or intolerance to the active ingredient or excipient of Herombopag Olamine tablets;
8. Pregnant or lactating women;
9. Participants who are participating in other clinical trials.
10. Other conditions that the investigator determines are not suitable for inclusion in the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Herombopag monotherapy

Experimental group

Treatment:

Drug: TPO-RA (Herombopag)

Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin)

Experimental group

Treatment:

Drug: TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin)