Solid tumor patients with thrombocytopenia caused by synchronous radiotherapy and chemotherapy treatment
Conditions
Interventions
Observation group of solid tumor patients with thrombocytopenia caused by synchronous radiotherapy and chemotherapy treatment:Romiplostim N01 for Injection
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, gender not limited; 2.Solid tumor patients diagnosed by histopathological or cytological examination, regardless of the type of cancer, are receiving synchronous radiotherapy and chemotherapy treatment; 3.Platelet count within 1 day before enrollment: 25 × 10^9/L = 12 weeks; 5.ECOG score for physical condition: 0-2 points; 6.The laboratory test indicators meet the following requirements: a) Renal function: Cr = 55ml/min; b) Liver function: Total bilirubin 38°C; 11.The subjects are able to understand the situation of this study and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Within the first 6 months of enrollment, there has been a decrease in platelets caused by non tumor therapy, including but not limited to liver cirrhosis, splenic hyperfunction, infection, and bleeding; 2.Known to have other hematopoietic system diseases, including leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome; 3.Known to have bone marrow invasion or metastasis; 4.Use ADC drugs during synchronous radiotherapy and chemotherapy; 5.After 3 weeks of infusion of red blood cells or erythropoietin (EPO) treatment, hemoglobin remains<50g/L, or after 1 week of treatment with granulocyte colony-stimulating factor (G-CSF), absolute neutrophil count remains<1.0 × 10 9/L; 6.Received pelvic and spinal radiation therapy within 3 months prior to enrollment; 7.History of arterial or venous thrombosis within 3 months prior to enrollment; 8.Patients with severe cardiovascular disease (such as NYHA heart function score III-IV) within the first 6 months of enrollment, known arrhythmias that increase the risk of thromboembolism such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass grafting; 9.Patients who are known or expected to be allergic or intolerant to the active ingredient or excipients of Lopsetin N01 (excipients include cellulose lactose, low substituted hydroxypropyl cellulose, magnesium stearate, film coated premix); 10.Pregnant or lactating women; 11.The researchers believe that it is not suitable for the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet count recovered to >= 100 × 10^9 within 2 weeks of treatment nine /The proportion of patients with L.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The median time for platelet count to recover to >= 75 × 10^9/L after treatment; 2. The proportion of patients whose platelet count recovered to >= 75 × 10^9/L within 2 weeks of treatment; three The;Adverse events and safety data such as laboratory tests, vital signs, electrocardiograms, etc; | — |
Countries
China
Contacts
Public ContactWang Linlin
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed