A randomized controlled clinical study of Avatrombopag combined with traditional Chinese medicine Shengxueyin and selenium yeast in the prevention of tumor chemotherapy-induced thrombocytopenia

Phase 1

Recruiting

• Conditions: Chemotherapy Induced Thrombocytopeniarapy

• Registration Number: ITMCTR2100005219
• Lead Sponsor: Huoshan County Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18 to 75 years, no gender limit;
2. Subjects diagnosed with tumors (gynecological tumors, digestive tract tumors, lung cancer, gastric cancer and head and neck tumors) by pathology or cytology and treated with two-drug platinum-containing chemotherapy;
3. Those with more than two-degree decrease in platelets after the previous cycle of chemotherapy; platelet count before or within 24 hours after chemotherapy is 40x10^9/L<=PLT<=100x10^9/L;
4. The subject's Eastern Cooperative Oncology Group (ECOG) performance status score is less than or equal to 2;
5. The life expectancy of subjects at screening is >=12 weeks, and they must continue to receive at least 2 cycles of the same chemotherapy regimen at screening;
6. Subjects of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the trial;
7. Subjects voluntarily and strictly abide by the requirements of the research protocol, and sign a written informed consent.

Exclusion Criteria

1. Received major surgery or minor surgery within 1 week before enrollment <= 3 days;
2. The subject has a history of arterial or venous thrombosis (such as myocardial ischemia, transient ischemic attack or stroke) within 6 months before screening;
3. Long-term bedridden subjects with severe vascular disease;
4. The subject has a history of chronic thrombocytopenia or hemorrhagic disease, or a history of thrombocytopenia caused by a cause other than tumor chemotherapy-induced thrombocytopenia (eg chronic liver disease or immune thrombocytopenic purpura or immunotherapy-induced thrombocytopenia);
5. The subject has a history of other malignant tumors, including hematological tumors, such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid malignant tumor, myelodysplastic syndrome, myeloproliferative disease and multiple myeloma, etc. ;
6. There are factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;
7. The subject has an allergic reaction to avatrombopag or any of its excipients;
8. Subjects participated in clinical research of other investigational drugs or devices within 30 days before screening;
9. As assessed by the investigator, the subject has any concomitant medical history that may impair the safety of the subject to complete the study, such as renal failure on hemodialysis or active infection that requires intravenous antibiotics;
10. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
11. Lactating subjects;
12. The investigator judges other circumstances that may affect the conduct of clinical research and the judgment of research results.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet value;