High-Risk Endometrial Cancer
Conditions
Interventions
Placebo group:Placebo plus standard therapy
Vortioxetine Group:Vortioxetine plus standard therapy
Sponsors
The international peace maternity and child health hospital
Eligibility
Sex/Gender
Female
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed newly diagnosed endometrial carcinoma or carcinosarcoma, meeting both of the following conditions:; a. Having undergone surgery, including total hysterectomy and bilateral salpingo-oophorectomy; b. Meeting the high-risk definition: All FIGO stages III-IVA, regardless of histological type and molecular classification (FIGO staging follows the 2009 edition); or FIGO stages I-II with p53 abnormal type and myometrial invasion; or FIGO stages I-II non-endometrioid type with myometrial invasion; 2. No residual local regional lesions or distant metastases after surgery; 3. No prior radiotherapy, chemotherapy, or systemic immunotherapy under any circumstances (including neoadjuvant therapy for endometrial cancer); 4. Age 25-75 years (inclusive at the time of signing the informed consent form); 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 6. Adequate function of major organs, meeting the following criteria:; a. Hematological test criteria: Hemoglobin (HGB) >=90 g/L; Absolute neutrophil count (NEUT) >=1.5×10?/L; Platelet count (PLT) >=80×10?/L; b. Biochemical tests must meet the following criteria: Total bilirubin (TBIL) =60 mL/min (calculated using the Cockcroft-Gault formula); c. Coagulation function tests must meet the following criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) <=1.5×ULN (for patients not receiving anticoagulant therapy); for patients receiving anticoagulant therapy, PT or APTT should be within the normal therapeutic range; 7. Voluntary participation in this study, signed informed consent, and good compliance.
Exclusion criteria
Exclusion criteria: 1. Recurrent endometrial carcinoma or recurrent carcinosarcoma; 2. FIGO Stage I or II endometrioid carcinoma without aberrant p53 expression or mutation; 3. FIGO Stage IVB endometrial carcinoma of any histological type; 4. Presence of residual disease after surgery; 5. History of other malignant tumors, unless curative treatment has been completed with no evidence of malignancy for 3 years; 6. Severe medical comorbidities, including cerebrovascular disease, renal failure, uncontrolled diabetes, uncontrolled hypertension and pulmonary diseases, severe infections, active peptic ulcer, patients with elevated intraocular pressure or at risk of acute angle-closure glaucoma, and other comorbidities that may interfere with the study treatment; 7. History of severe cardiovascular diseases: myocardial ischemia or myocardial infarction of Class II or above, poorly controlled arrhythmias (including QTc interval >=470 ms in females); cardiac dysfunction of Class III–IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <50% as measured by echocardiography; pregnant or lactating women; 8. Active or uncontrolled severe infection; 9. Any contraindication to the use of carboplatin or paclitaxel or other chemotherapeutic agents; 10. History of severe psychiatric disorders or epilepsy; previous or current use of vortioxetine or selective serotonin reuptake inhibitors (SSRIs); 11. Use of irreversible non-selective monoamine oxidase inhibitors (MAOIs) within 14 days prior to enrollment, or current use of reversible selective MAO-A inhibitors, reversible non-selective MAOIs, or irreversible selective MAO-B inhibitors; 12. Allergy to vortioxetine; 13. Other acute or chronic severe medical or psychiatric conditions (including recent or active suicidal ideation or behavior) or laboratory abnormalities that may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and which, in the judgment of the investigator, would make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival, DFS;Overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs);EORTC QLQ C30;PHQ-9;GAD-7;PSQI; | — |
Countries
China
Contacts
Public ContactYudong Wang
The international peace maternity and child health hospital
Outcome results
None listed