Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors

This is an interventional treatment trial for Thrombocytopenia focused on measuring chemotherapy, rh-TPO, avatrombopag Read More

Inclusion Criteria:

1. Male or female, aged 18~75 years.
2. Diagnosed with malignant tumors (gynecological tumors, gastrointestinal tumors, lung cancer, gastric cancer and head and neck tumors) by pathology or cytology and need chemotherapy.
3. The subject had developed at least grade II thrombocytopenia after the last chemotherapy cycle (10×109/L<PLT count<75×109/L).
4. Subjects' Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.
5. The subjects' life expectancy at the time of screening is ≥12 weeks, and must continue to receive at least 2 cycles of the same chemotherapy regimen at the time of screening.
6. Women of childbearing age must have taken reliable contraceptive measures, or have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial.
7. The subjects voluntarily and strictly abide by the requirements of the research protocol and sign a written informed consent.

Exclusion Criteria:

1. Subjects suffer from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; according to NYHA standards, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination suggests left ventricular ejection fraction ( LVEF) <50%.
2. Subjects have clinically significant acute or active bleeding (such as gastrointestinal or central nervous system) within 7 days before screening.
3. Subjects received major surgery or minor surgery within 4 weeks of enrollment ≤ 3 days.
4. Subjects had a history of arterial or venous thrombosis (such as myocardial ischemia, transient ischemic attack, or stroke) within 6 months before screening.
5. Subjects had active infection or acute infection occurred within 2 weeks before the first administration of the study.
6. Long-term bed rest, subjects with severe vascular disease.
7. Subjects had a history of chronic thrombocytopenia or bleeding disorders, or a history of thrombocytopenia (such as chronic liver disease or immune thrombocytopenic purpura) caused by causes other than thrombocytopenia caused by chemotherapy.
8. Subjects had a history of other malignant tumors, such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignant tumor, myelodysplastic syndrome, myeloproliferative disease, and multiple myeloma.
9. There are factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction.
10. Subjects had an allergic reaction to avatrombopag or any of its excipients.
11. Subjects participated in clinical studies of other study drugs or devices within 30 days before screening.
12. The investigator assessed that the subjects had any accompanying medical history that could impair the subject's safety in completing the study, such as renal failure due to hemodialysis or active infection requiring intravenous antibiotics.
13. Subjects had a history of psychotropic drug abuse and unable to quit or have mental disorders.
14. Pregnant or breastfeeding women, and fertile patients who are unwilling or unable to take effective contraceptive measures.
15. The investigator judges other conditions that may affect the conduct of clinical research and the determination of research results.