Gynecological Malignant Tumors, including cervical cancer, endometrial cancer, ovarian cancer, vulvar cancer, and vaginal cancer.
Conditions
Interventions
Experimental Group:Romiplostim N01 and pelvic radiotherapy
Initial dose 1 µg/kg SC once weekly, starting 1 week before RT and continuing through 4 weeks post-RT.
(SC = subcutaneous
RT = radiotherapy)
Control group:supportive care and pelvic radiotherapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age and Gender: Female patients aged 18-75 years. The upper age limit is set considering the tolerance and comorbidity risk in elderly patients. 2.Disease Diagnosis: Patients with a histopathologically or cytologically confirmed diagnosis of gynecologic malignancies, including but not limited to cervical cancer, endometrial cancer, ovarian cancer, vulvar cancer, or vaginal cancer. 3.Treatment Plan: Patients with gynecologic malignancies who are scheduled to receive standard treatment (including but not limited to pelvic radiotherapy, concurrent chemoradiotherapy, or chemotherapy). 4.Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, ensuring patients have adequate physical fitness to tolerate the treatment and study procedures. 5.Life Expectancy: Expected survival of at least 6 months, ensuring patients can complete the study observation period. 6.Organ Function: Baseline organ function must meet the following requirements: Hematologic Function: Hemoglobin >=90 g/L, white blood cell count >=3.0×10^9/L, absolute neutrophil count >=1.5×10^9/L, platelet count between 100-300×10^9/L; Liver Function: Total bilirubin =50 mL/min. 7.Informed Consent: Patients must understand the study content and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Hematologic Diseases: Previous or current hematologic malignancies (e.g., leukemia, lymphoma, etc.), clinically diagnosed myelodysplastic syndrome (MDS), aplastic anemia, myelofibrosis, or other hematologic diseases (bone marrow aspiration is not used as a screening method for study enrollment. If a patient has a clear history or clinical manifestations of hematologic disease, a definitive diagnosis must be made before enrollment).atologic disease, a definitive diagnosis must be made before enrollment). 2.History of Thrombosis: History of thromboembolic events within the past 6 months, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, etc. 3.Bleeding Tendency: Active bleeding or a tendency to bleed, with coagulation abnormalities (PT or APTT exceeding 1.5 times the upper limit of normal). 4.Prior Treatment: Received chemotherapy, radiotherapy, or other anti-tumor therapy within 4 weeks; prior pelvic radiotherapy; use of medications affecting platelet function within 4 weeks. 5.Comorbidities: Severe cardiovascular disease, liver or renal insufficiency, active infection, autoimmune diseases, or other serious comorbidities. 6.Allergy History: Known allergy to Romiplostim N01 or any of its components. 7.Pregnancy and Lactation: Women who are pregnant or breastfeeding. 8.Compliance: Patients unable to comply with the requirements of the study protocol or unable to cooperate with follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 or Higher Thrombocytopenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiotherapy completion rate;Duration of hematologic toxicity;Incidence of complications (infection, hemorrhage);Quality of Life Rating;Adverse events, serious adverse events; | — |
Countries
China
Contacts
Public ContactJi Ma
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed