Cervical cancer
Conditions
Interventions
Experimental Group:Romiplostim N01 for injection
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Cervical cancer confirmed by histopathology, clinical stage IB3, IIA2, IIB-IVA (according to the 9th edition of the International Union Against Cancer and the American Joint Committee on Cancer (UICC/AJCC) in 2021); 3. Patients undergoing concurrent chemoradiotherapy (pelvic EBRT + intracavitary afterloading radiotherapy; Chemotherapy uses a 21-day platinum-containing regimen) (the patient's prior treatment mode before starting concurrent chemoradiotherapy is not limited); 4. Patients experiencing thrombocytopenia during concurrent chemoradiotherapy. , and platelet count =75×109/L within 3 days before enrollment; 5. Expected survival time at screening >=12 weeks; 6. ECOG score of 0, 1 or 2; 7. Women of childbearing age who agree to take contraceptive measures during the study and within 6 months after the study and male patients who are not breastfeeding agree to take contraceptive measures during the study and within 6 months after the study; 8. Have not participated in clinical trials of other drugs within 4 weeks before enrollment; 9. Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from hematopoietic system diseases, including lymphoma, leukemia, aplastic anemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome; 2. Experiencing thrombocytopenia caused by non-tumor treatment within 6 months before screening, including but not limited to EDTA-dependent pseudothrombocytopenia, hypersplenism, infection, bleeding, etc. 3. Brain tumor, brain metastasis, bone marrow invasion or bone marrow metastasis; 4. Transfusion of red blood cells or erythropoietin (EPO) ) After treatment, hemoglobin is still <50g/L, or after treatment with granulocyte colony stimulating factor (G-CSF), the absolute neutrophil count is still <1.0×10^9/L; 5. Any arterial or venous thrombosis occurred within 6 months before screening; 6. Screening for severe cardiovascular disease (such as NYHA heart function score III-IV), arrhythmias that increase the risk of thrombosis (such as atrial fibrillation), coronary artery stenting, angioplasty and coronary artery bypass grafting in the past 6 months; 7. Patients who have received platelet transfusion within 5 days before the trial drug administration; 8. Patients who have received thrombopoietin receptor agonist treatment within 4 weeks before the trial drug administration, human recombinant thrombopoietin (rhTPO) or rhIL-11 treatment within 4 weeks, or other Chinese medicine with platelet-raising effect within 1 week; 9. Patients with positive hepatitis C antibody and HCV-RNA test exceeding the standard, patients with positive hepatitis B surface antigen and HBV-DNA test exceeding the standard, patients with severe liver cirrhosis, patients with positive HIV antibody, patients with positive syphilis antibody; 10. During the screening period, for subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3ULN; For subjects with liver metastasis = 5ULN; 11. Serum creatinine concentration = 1.5ULN or eGFR = 60ml/min; 12. Patients with known allergy or intolerance to the active ingredient or excipients of Roprografen N01 for injection; 13. Planning to become pregnant, pregnant or breastfeeding; 14. The investigator judges that the patient is not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with PLT >= 100×10^9/L within 3 weeks after treatment with romiplostim N01; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to PLT >= 100×10^9/L;Proportion of patients receiving platelet transfusions for thrombocytopenia;The number of platelet counts <100×10^9/L during concurrent chemoradiotherapy;The lowest platelet count during concurrent chemoradiotherapy;The incidence of dose adjustment, delay, and discontinuation of chemoradiotherapy due to thrombocytopenia;The incidence of serious adverse events was recorded according to CTCAE 5.0 criteria; | — |
Countries
China
Contacts
Public ContactFeng Mei
Sichuan Cancer Hospital
Outcome results
None listed