Recurrent Ovarian Cancer
Conditions
Interventions
Test group:Paroxetine combined with chemotherapy
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 or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 2. Definition of relapse must meet ANY one of the following two criteria: a. Presence of measurable lesions per RECIST 1.1 criteria; b. Persistent elevation of tumor marker CA125 (confirmed after 1 week) accompanied by clinical symptoms or signs. 3. Age 25–75 years (inclusive at the time of signing informed consent form). 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 5. Life expectancy >= 3 months. 6. Adequate organ function, defined as follows: a. Hematological criteria: Hemoglobin (HGB) >= 90 g/L; Absolute Neutrophil Count (NEUT) >= 1.5 × 10?/L; Platelet count (PLT) >= 80 × 10?/L; b. Biochemical criteria: Total Bilirubin (TBIL) = 60 mL/min (calculated by Cockcroft-Gault formula); c. Coagulation criteria: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR) <= 1.5 × ULN (for patients not receiving anticoagulant therapy); for patients on anticoagulant therapy, PT or APTT should be within the therapeutic range. 7. Voluntarily participate in the study, sign the informed consent form, and demonstrate good compliance.
Exclusion criteria
Exclusion criteria: 1. Presence of 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, or other comorbidities that may interfere with the study drug treatment. 2. History of severe cardiovascular diseases: myocardial ischemia of Grade II or above, or myocardial infarction; poorly controlled arrhythmias (including QTc interval >=470 ms in females); cardiac dysfunction of Class III–IV per NYHA criteria, or left ventricular ejection fraction (LVEF) <50% as indicated by echocardiography; pregnant or lactating women. 3. Active or uncontrolled severe infection. 4. History of epilepsy requiring treatment. 5. Known hypersensitivity to paroxetine. 6. Use of monoamine oxidase inhibitors (MAOIs), thioridazine, or pimozide within the past two weeks or currently. 7. Any other acute or chronic medical or psychiatric condition (including recent or active suicidal ideation or behavior) or laboratory abnormality 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 |
|---|---|
| objective response rate, ORR;disease control rate, DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS Rate at 12 Months;Incidence and severity of AEs and SAEs;Overall survival, OS;progression-free survival, PFS;PFS Rate at 6 Months;EORTC QLQ C30;GAD-7;PHQ-9;PSQI; | — |
Countries
China
Contacts
Public ContactYudong Wang
The International Peace Maternity and Child Health Hospital
Outcome results
None listed