Chemotherapy associated thrombocytopenia in colorectal cancer
Conditions
Interventions
Group 1:Subcutaneous injection into the abdomen, starting at a dose of 2 µ g/kg, once a week
The subsequent dosage will be adjusted based on the patients platelet count.
Group 2:RhIL-11: Subcutaneous injection at a dose of 25-50 µ g/kg 1-2 days after chemotherapy, once daily or every other day, for 7-10 consecutive days or to meet the discontinuation criteria
Group 3:Ropustine N01: Subcutaneous injection in the abdomen, starting dose 2 µ g/kg, once a week
The subsequent dosage will be adjusted based on the patients platelet count.
rhIL-11: Subcutaneous injection at a dose of 25-50 µ g/kg 1-2 days after chemotherapy, once daily or every other day, for 7
Sponsors
Tianjin People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old at the time of signing the informed consent; 2. Histopathological or cytological examination to confirm the diagnosis of colorectal cancer, requiring the use of one or more chemotherapy drugs; 3. The patient's previous cycle of chemotherapy is eligible for secondary prevention; 4. Predicted survival at screening>=3 months, and expected to be able to use the current chemotherapy cycle>=2 cycles; 5. ECOG scoring scale is 0-2; 6. Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form. 7. The platelet count of patients before administration >=75×10^9/L.
Exclusion criteria
Exclusion criteria: 1. In the current anti-tumor stage, the platelet count before the first chemotherapy is less than 75 × 10^9/L; 2. Suffering from hematopoietic system diseases, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome; 3. Other causes of thrombocytopenia besides CIT (such as chronic liver disease, history of immune thrombocytopenic purpura, etc.); 4. Have received abdominal, pelvic, or sternal radiation therapy within the past 3 months prior to undergoing radiation therapy or screening; 5. History of thrombosis within 3 months prior to the first administration; 6. Severe cardiovascular disease within 6 months prior to the first administration; 7. Clinical manifestations of severe bleeding (such as gastrointestinal bleeding, etc.) within 4 weeks before the first administration; 8. Have a tendency towards thrombosis or are currently receiving thrombolytic/anticoagulant therapy; 9. Significant abnormalities in liver function; 10. Abnormal renal function; 11. Known or expected allergy or intolerance to the active ingredients or excipients of the test drug (including cellulose lactose, low substituted hydroxypropyl cellulose, magnesium stearate); 12. Have participated in any other clinical study of the investigational drug or device within 28 days prior to the first administration; 13. Patients planning pregnancy, pregnancy, or lactation; 14. The researcher determines that patients who are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR of rosuvastatin N01 on the 21st day of chemotherapy after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet count depth;Time to first platelet reaction;There was no incidence of subjects experiencing a delay of = 4 days in the next chemotherapy cycle due to thrombocytopenia;Thrombosis incidence rate;Incidence of platelet transfusion;Safety; | — |
Countries
China
Contacts
Public ContactHao Yan
Tianjin People's Hospital
Outcome results
None listed