Chemotherapy-induced thrombocytopenia associated with adjuvant chemotherapy in colorectal cancer patients
Conditions
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old, gender unlimited; 2.Patients with colorectal cancer diagnosed by histopathology or cytology, regardless of clinical stage, should receive radical resection of colorectal cancer; 3.Subjects were receiving platinum-containing chemotherapy regimen (XELOX: oxaliplatin combined with capecitabine); 4.Patients with platelet counts <100×10^9/L before enrollment had chemotherapy interruption or researchers determined that chemotherapy might be delayed; 5.Subjects must have at least 2 remaining scheduled chemotherapy cycles; 6.The physical status of the Eastern Tumor Collaboration group (ECOG) was 0, 1 or 2; 7.For women of reproductive age, consent to use contraception during the study period and for 6 months after the study ends; 8.And non-lactating patients; 9.Male patients who agreed to use contraception during the study period and for 6 months after the study ended. Did not participate in clinical trials of other drugs within 4 weeks before enrollment; 10.Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with hematopoietic diseases, including lymphoma, leukemia, aplastic anemia, idiopathic thrombocytopenic purpura, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome; 2.Previously received pelvic radiotherapy for any reason; 3.Have experienced non-tumor treatment induced thrombocytopenia within 6 months prior to screening, including but not limited to EDTA-dependent pseudo thrombocytopenia, hypersplenia or splenomegalia, infection, bleeding, etc. 4.Brain tumor, brain metastasis, bone marrow invasion or bone metastasis; 5.Hemoglobin was still =3 ULN for subjects without liver metastasis; 12.>=5 ULN for subjects with liver metastases; 13.Serum creatinine concentration >=1.5 ULN or eGFR<=60ml/min; 14.Patients with known allergy or intolerance to the active ingredient or excipient of Ropristim N01 for injection; 15.Planning pregnancy, pregnancy or lactation; 16.The investigator judged that the patient was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood platelet count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood platelet count;Blood platelet count;Incidence of chemotherapy dose adjustment, delay, discontinuation due to thrombocytopenia;Number and percentage of patients with thrombocytopenia receiving platelet transfusions;Incidence of serious adverse events;The time it takes for the platelet count to rise to 75×10^9/L for the first time; | — |
Countries
China
Contacts
Public ContactHang Zhou
Sichuan Cancer Hospital
Outcome results
None listed