Tumor
Conditions
Interventions
Ropstin N01 Group:Subcutaneous injection of roplastine N01
Control Group:Receive rhTPO/rhIL-11 treatment.
Sponsors
Weifang people's hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old; 2.Patients with solid tumors with definite pathological diagnosis and imaging evidence; 3.The patient received first-line chemotherapy combined with immunotherapy, and the platelet count before the first chemotherapy was > 100× 10^9/L; 4.There is grade II or above thrombocytopenia (platelet count < 75×10^9/L) caused by anti-tumor therapy, and there is no bleeding event; 5.ECOG physical fitness score <=2; 6.The estimated survival time is more than 3 months; 7.Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of hematological malignancies, including leukemia, myeloma, myeloproliferative diseases, lymphoma or myelodysplastic diseases; 2.Patients diagnosed with bone marrow infiltration; 3.Patients with hemoglobin 3 times the upper limit of normal value or total bilirubin > 3 times the upper limit of normal value should be excluded. If there is primary or metastatic liver cancer, ALT and AST > 5 times the upper limit of normal value or total bilirubin > 5 times the upper limit of normal value should be excluded. 5.Patients who have a history of symptomatic venous thrombosis events (such as deep venous thrombosis and pulmonary embolism) or symptomatic arterial thrombosis events (such as myocardial infarction, ischemic stroke and transient ischemic attack) and cannot tolerate anticoagulant therapy are not eligible. Patients who continue to receive anticoagulant therapy or have completed the prescribed course of anticoagulant therapy can be enrolled in the group. Central venous catheter-related venous thrombosis events did not affect the eligibility; 6.Serious accompanying diseases that may interfere with clinical trials, including unstable angina pectoris, renal failure requiring hemodialysis or active infection requiring intravenous infusion of antibiotics; 7.People who are known to be seropositive for Human Immunodeficiency Virus, HIV); People with active autoimmune diseases; 8.Pregnant or lactating women; 9. platelet transfusion, rhTPO, rhIL-11, TPO-RA, and traditional Chinese medicine or Chinese patent medicine, chemical medicine or biological medicine with the function of increasing platelet count within one week before joining the group; 10. Participated in any clinical trials of drugs in recent 3 months; 11. Patients with serious psychological or mental disorders, cognitive impairment and other factors affecting drug evaluation; 12.The researcher thinks that there are other factors that are not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet recovery time; | — |
Secondary
| Measure | Time frame |
|---|---|
| On-time delivery rate of chemotherapy in the next cycle;Platelet transfusion times;Incidence rate of bleeding events;Absolute value of platelet count;Platelet recovery efficiency;Minimum platelet count; | — |
Countries
China
Contacts
Public ContactLiu Shuzhen
Weifang people's hospital
Outcome results
None listed