Concurrent chemoradiation-induced thrombocytopenia
Conditions
Interventions
Experimental group :Hetrombopag Olamine Tablets
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75, male or female; 2. Patients with malignant tumor confirmed by histopathological or cytological examination, with no limitation of cancer type, presenting with thrombocytopenia during radical concurrent chemoradiotherapy; 3. Platelet count =12 weeks; 5. ECOG PS score: 0-2; 6. Laboratory inspection indicators meet the following requirements: (1) Renal function: Cr=55 mL /min; (2) Liver function: total bilirubin 38 degree centigrade; 11. The subjects can understand the study situation and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Occurrence of thrombocytopenia, including but not limited to cirrhosis, hypersplenism, infection, and bleeding, within 6 months prior to screening due to non-tumor treatment; 2. Other diseases of the hematopoietic system, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, except thrombocytopenia caused by concurrent radiotherapy and chemotherapy for malignant tumors; 3. Complicated with bone marrow invasion or bone marrow metastasis; 4. Hemoglobin was still < 80g/L after erythrocyte infusion or erythropoietin (EPO) treatment, or absolute value of neutrophil was still < 1.0*10^9/L after granulocyte colony stimulating factor (G-CSF) treatment; 5. The chemotherapy regimen in concurrent chemoradiotherapy is capecitabine, tegio and other chemotherapy drugs that need oral treatment for a long time; 6. Had received pelvic and spinal radiotherapy and bone field irradiation within 3 months prior to screening; 7. Any history of arterial or venous thrombosis in the 6 months prior to screening; 8. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within 2 weeks prior to screening; 9. Received platelet transfusion within 2 days before enrollment; 10. During the preceding 6 months, patients were screened for serious cardiovascular disease (such as NYHA Grade III to IV cardiac function score), arrhythmias known to increase the risk of thromboembolism, such as atrial fibrillation, after coronary stenting, angioplasty, and after coronary artery bypass graft; 11. Received human recombinant thrombocytopoietin (rhTPO) or human recombinant interleukin-11 (RHIL-11) or thrombocytopoietin receptor agonists (e.g. Altrepoipa, avatripoipa) within 14 days prior to screening; 12. Patients with known or expected allergy or intolerance to the active ingredients or excipients of Hytropoethanolamine tablets (excipients include: cellulose-lactose, low-substituted hydroxypropyl cellulose, magnesium stearate, film coated premix); 13. Nursing women; 14. Vulnerable groups, including the mentally ill, cognitively impaired, critically ill, minors, pregnant women, etc.; 15. Those considered unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients whose platelet count returned to >= 100*10^9/L during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required for platelet count to recover from the lowest value to >= 100*10^9/L during treatment;The lowest platelet count during treatment;The lowest platelet count during maintenance;Difference of platelet count between the end and the beginning of concurrent chemoradiotherapy;Proportion of concurrent chemotherapy suspension due to thrombocytopenia;Platelet infusion times;Platelet infusion volume; | — |
Countries
China
Contacts
Public ContactSun Xiaonan
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed