A Multicenter, Randomized, Self-controlled Exploratory Clinical Study of Hetrombopag Olamine Tablets for Thrombocytopenia Induced by Anti-tumor Treatment in Advanced Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Henan Cancer Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The response rates to platelet-raising therapy in prevention stage
Study Overview
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 hetrombopag in chemotherapy-induced platelets.
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 malignancies. Thrombopoietin receptor agonist (TPO-RA) has a therapeutic effect on cancer therapy-induced thrombocytopenia (CTIT). As an innovative TPO-RA drug, hetrombopag has a more optimized molecular structure and reduced liver and kidney toxicity. A registrational Phase III clinical study in CTIT patients is ongoing. 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 hetrombopag in therapy-induced platelets.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •The main organ functions are normal, and there are no serious complications.
Exclusion Criteria
- •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;
- •Received platelet transfusion within 3 days before randomization;
- •Patients with known or expected hypersensitivity or intolerance to the active ingredients or excipients of Hetrombopag ethanolamine tablets.
Arms & Interventions
hetrombopag Olamine tablets
The first anti-tumor treatment cycle (multicenter, open label, randomized controlled):
When platelets were <50*109/L, oral hetrombopag 7.5 mg/day was started. When the platelet count is >100*109/L, the administration is suspended.
2nd anti-tumor treatment cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after anti-tumor treatment for 14 days.
Intervention: Hetrombopag (Drug)
rhTPO
The first anti-tumor treatment cycle (multicenter, open label, randomized controlled):
Start using rh-TPO 15000 units/day (subcutaneous injection) when platelets are less than 50*109/L. When the platelet count is more than 100*109/L, the administration is suspended.
2nd anti-tumor treatment cycle (exploratory study): Prophylactic use (60 cases in the test group and the control group): oral hetrombopag 7.5 mg/day (initial dose) was started on d2 after anti-tumor treatment for 14 days.
Intervention: Hetrombopag (Drug)
Outcomes
Primary Outcomes
The response rates to platelet-raising therapy in prevention stage
Time Frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
The response rate defined as the proportion of pts not requiring platelet transfusion or adjustment (dose reduction 20%, treatment delays for ≥5 days, or treatment discontinuation) due to thrombocytopenia, and not developing severe thrombocytopenia (PLT \< 25×10⁹/L, or PLT \<50×10⁹/L for \>7 days).
Secondary Outcomes
- The response rate to platelet-raising therapy in treatment stage;(30day±3day after the last administration of Hetrombopag Olamine Tablets or rh TPO)
- The lowest platelet value after anti-tumor treatment;(30day±3day after the last administration of Hetrombopag Olamine Tablets)
- The incidence of platelets <50×109/L and <25×109/L;(30day±3day after the last administration of Hetrombopag Olamine Tablets)
- The duration of platelets <50×109/L and <25×109/L;(30day±3day after the last administration of Hetrombopag Olamine Tablets)
- The time for platelets to recover to more than 100×109/L;(30day±3day after the last administration of Hetrombopag Olamine Tablets)
- latelet recovery to the highest value after anti-tumor treatment;(30day±3day after the last administration of Hetrombopag Olamine Tablets)
- the incidence of adverse events;(30day±3day after the last administration of Hetrombopag Olamine Tablets)