Cancer therapy-induced thrombocytopenia
Conditions
Interventions
Queue 1:Starting from day 2 after chemotherapy, oral administration of hertrombopag ethanolamine tablets at a dose of 5mg per day (the initial dose) was initiated for 14 consecutive days. Blood routin
Queue 2:Starting from day 2 after chemotherapy, oral administration of hertrombopag ethanolamine tablets at a dose of 5mg per day (the initial dose) was initiated for 14 consecutive days. Blood routin
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 -75 years old, gender not limited. 2. Breast cancer patients diagnosed by histopathological or cytological examination; 3. Cohort 1: Planned to receive ADC drug treatment; Cohort 2: Patients who received ADC drug treatment in the previous chemotherapy cycle and had a minimum PLT value of less than 75×10^9/L are expected to maintain the same chemotherapy regimen for >=2 cycles. 4. Expected survival period >=12 weeks; 5. Physical condition ECOG PS score: 0-2 points; 6. The laboratory inspection indicators meet the following requirements: (1) Renal function: Cr=55 ml/min; (2) Liver function: Total bilirubin 38?; 11. Those with good expected compliance can follow up on the therapeutic effect and adverse reactions as required by the protocol.
Exclusion criteria
Exclusion criteria: Screening or baseline platelet value 3ULN (upper limit of normal value), and TBIL > 3ULN; Patients with liver metastasis have ALT/AST>=5ULN and TBIL>=5ULN. 13. Abnormal renal function: Serum creatinine >=1.5ULN or eGFR<=60 ml/min (Cockcroft-Gault formula) 14. Platelet transfusion was received within 2 days before enrollment; 15. Received treatment with human recombinant thrombopoietin (rhTPO), human recombinant interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatracopag) within 10 days before screening; 16. Patients who are known or expected to be allergic to or intolerant to the active ingredients or excipients of heltrombopag ethanolamine tablets (excipients include: cellulose-lactose, low-substitution hydroxypropyl cellulose, magnesium stearate, film-coated premixes); 17. Pregnant or lactating women; 18. Those who were considered unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of Grade 3 and above Cancer Therapy - Induced Thrombocytopenia (CTIT); | — |
Secondary
| Measure | Time frame |
|---|---|
| The duration of Grade 3 and above Cancer Therapy-Induced Thrombocytopenia (CTIT);The proportion of patients with delayed ADC treatment;The proportion of patients with reduced ADC treatment doses;The percentage of subjects receiving emergency treatment;The proportion of patients undergoing platelet transfusion; | — |
Countries
China
Contacts
Public ContactNani Li
Fujian Cancer Hospital
Outcome results
None listed