Gynecological Cancer
Conditions
Interventions
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients (18 years of age or greater) with malignant gynecological tumor (including endometrial cancer, ovarian cancer, cervical cancer, carcinoma of vulva and so on). 2. Adequate renal function; serum creatinine 100×10^9/L) before the start of chemotherapy. 4. KPS >= 50 or ECOG performance status 0-1. 5. Ability to provide written informed consent. 6. Absolute neutrophil count (ANC) >= 1.0*10^9/L, hemoglobin >=80 g/L, and platelet count >= 100 *10 ^9/L on Day 1 of the first on study chemotherapy treatment cycle. 7. Thrombocytopenia as evidenced by a platelet count <= 75*10^9/L during the qualifying cycle of chemotherapy, and this criteria ensures that the patient must be dose delayed for platelet recovery
Exclusion criteria
Exclusion criteria: 1. Subjects with an active infection; sepsis, disseminated intravascular coagulation, or any other condition (i.e. myelodysplastic syndrome {MDS}, immune thrombocytopenic purpura {ITP}, thrombotic thrombocytopenic purpura {TTP}, hemolytic uremic syndrome {HUS}, hypersplenism and so on) that may have exacerbated thrombocytopenia. 2. New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be stable and suitable for continued therapeutic anticoagulation during trial participation. 3. Patients with known bone metastases, with evidence of corticol bone damage/lytic lesions/blastic lesions on standard imaging studies (CT/MR). 4. Have ever received radiation therapy. 5. Other malignancies diagnosed in the previous 5 years before enrolment (except cured skin basal cell carcinoma, etc.). 6. Anemia (Hgb 3*ULN or Total Bili >3*ULN. 8. Serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics. 9. Pregnant women/lactating mothers. 10. Patients unwilling to use contraception. 11. Previous treatment with thrombopoietin receptor agonists (e.g., romiplostim, eltrombopag), recombinant human thrombopoietin (rhTPO), or rhIL-11 within 4 weeks prior to enrollment; use of other platelet-elevating agents (including but not limited to Caffeic acid Tablets, Leucogen Tablets, Shengxuening Tablets) prior to the first dose of the study drug with an interval shorter than 5 drug half-lives; or administration of anticoagulants (e.g., heparin, warfarin, aspirin) within 5 days before the first dose, except for heparin used for catheter locking purposes. 12. Have received the platelet transfusion within 4 weeks. 13. Have received any experimental therapy within 4 weeks prior to screening. 14. Have ever received a bone marrow or peripheral blood stem cell infusion (within 1 year of screening). 15. Known hypersensitivity to any recombinant E. coli-derived product. 16. Psychiatric diseases or conditions that might impair the ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients whose platelet counts recovered to =100×10^9/L;Treatment related adverse events, TRAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients whose platelet counts recovered to 75×10^9/L;Time for platelet recovery to 100×10^9/L;The proportion of chemotherapy delay or dose adjustment due to thrombocytopenia; | — |
Countries
China
Contacts
Public ContactYingmei Wang
Tianjin Medical University General Hospital
Outcome results
None listed