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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, China
The response rates to platelet-raising therapy in prevention stage
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).
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
The response rate to platelet-raising therapy in treatment stage;
The response rate defined as the treatment 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).
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets or rh TPO
The lowest platelet value after anti-tumor treatment;
The lowest platelet value after anti-tumor treatment;
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
The incidence of platelets <50×109/L and <25×109/L;
The incidence of platelets \<50×109/L and \<25×109/L;
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
The duration of platelets <50×109/L and <25×109/L;
The duration of platelets \<50×109/L and \<25×109/L;
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
The time for platelets to recover to more than 100×109/L;
The time for platelets to recover to more than 100×109/L;
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Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
latelet recovery to the highest value after anti-tumor treatment;
latelet recovery to the highest value after anti-tumor treatment;
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets
the incidence of adverse events;
the incidence of adverse events;
Time frame: 30day±3day after the last administration of Hetrombopag Olamine Tablets