Advanced ovarian cancer
Conditions
Interventions
Placebo group:240mg/m2,Q3W
Trilaciclib group:240mg/m2,Q3W
Sponsors
Sun yat-sen memorial hospital, Sun yat-sen university
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Patients voluntarily joined the study and signed an informed consent form; (2) Female patients aged 18 years or older; (3) Previously untreated, incompletely resectable Stage III or any Stage IV (FIGO Stage III or IV) epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; with an expected survival of at least 3 months; (4) Patients with an ECOG score of 0-1; (5) Laboratory test results meeting the following criteria: Hemoglobin >= 80 g/L; Absolute neutrophil count >=1.5 × 10^9/L; Platelet count >= 80 × 10^9/L; Serum creatinine = 30 g/L; (6) Willingness to communicate with the investigator, ability to understand and comply with trial requirements, and willingness and ability to adhere to visit schedules, dosing plans, laboratory tests, and other clinical study procedures.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with malignancies other than ovarian cancer within 5 years prior to the first dose (excluding radically cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ); (2) Patients with uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA Class III or IV); (3) Patients with stroke or cerebrovascular events within 6 months before enrollment; (4) QTcF interval > 480 msec at screening, or QTcF > 500 msec for patients with ventricular pacemakers; (5) Previous hematopoietic stem cell or bone marrow transplantation; (6) Hypersensitivity to trilaciclib or or any of its ingredients; (7) Pregnant or lactating women; women of childbearing age with positive blood pregnancy test during screening; (8) Other ineligible for trial as judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of >= grade 3 neutropenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of >= grade 3 haemoglobin decreased;Incidence of >= grade 3 thrombocytopenia;Progression-free survival (PFS) ;Overall survival;Duration of hospital stay associated with chemotherapy-induced myelosuppression;Effect of treaclib on quality of life in newly treated or recurrent ovarian cancer; | — |
Countries
China
Contacts
Public ContactJunyan Wu/Rao Qunxian
Sun yat-sen memorial hospital, Sun yat-sen university
Outcome results
None listed