Status:
RECRUITING
A Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This study now plans to explore the efficacy and safety of hetrombopag in cancer therapy-induced thrombocytopenia in advanced breast cancer, so as to further guide the clinical application of hetrombo...
Detailed Description
Cancer therapy-induced thrombocytopenia increases the risk of hemorrhagic complications, the need for platelet transfusions, and limits the dose of cytotoxic drugs in the treatment of certain malignan...
Eligibility Criteria
Inclusion
- The patients signed the informed consent and voluntarily joined the study;
- Age 18-75 years old, male or female;
- Patients with advanced breast cancer diagnosed by histopathology or cytology, who are receiving and continue to receive the same chemotherapy regimen;
- Can accept the current chemotherapy regimen (must be platinum-containing chemotherapy regimen: lobaplatin, carboplatin, cisplatin, etc.) for at least 2 cycles;
- The first occurrence of platelets \<50×109/L in the current chemotherapy cycle;
- The investigator determines that the patient can receive hetrombopag administration;
- Neutrophil count ≥ 1.0×109/L, hemoglobin ≥ 80g/L before administration of Haitrombopag;
- Life expectancy at screening ≥ 12 weeks;
- ECOG: 0-1;
- The main organ functions are normal, and there are no serious complications.
Exclusion
- Women who are pregnant or breastfeeding;
- Unable to understand the research nature of the research or have not obtained informed consent;
- The investigator judges other circumstances that are not suitable for inclusion in the study;
- Thrombocytopenia caused by other causes (chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
- Patients with unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent history (within 1 year of screening) of myocardial infarction;
- Those with a history of blood disease or tumor bone marrow infiltration;
- Those who received simultaneous radiotherapy and those who received pelvic radiotherapy in the past;
- Arterial or venous thrombotic events within the past 6 months;
- There are currently uncontrollable infections;
- Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal or central nervous system bleeding;
- Need emergency treatment, such as superior vena cava syndrome, spinal cord compression;
- The absolute value of neutrophils is less than 1.0×109/L, and the hemoglobin is less than 80g/L, and granulocyte colony-stimulating factor, red blood cells, and EPO infusion therapy in accordance with clinical routine are allowed;
- Obvious abnormal liver function: patients without liver metastases, ALT/AST\>3ULN (upper limit of normal value), TBIL\>3ULN; patients with liver metastases, ALT/AST≥5ULN, TBIL≥5ULN;
- Abnormal renal function: serum creatinine ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft-Gault formula);
- 16\. Received thrombopoietin receptor agonist drugs (such as Eltrombopag, Romigrastim), or recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL) within 1 month before screening -11) Treatment; 17. Received platelet transfusion within 3 days before randomization; 18. Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of Hetrombopag ethanolamine tablets.
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05394285
Start Date
August 19 2022
End Date
August 1 2025
Last Update
July 17 2025
Active Locations (2)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China
2
Henan Cancer Hospital
Zhengzhou, China