Platinum-sensitive ovarian cancer
Conditions
Interventions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject understands the trial process, signs the informed consent form, and agrees to participate in the study. 2. Female aged 18 years or older. 3. Newly diagnosed non-mucinous advanced (FIGO stage III/IV) epithelial ovarian cancer confirmed by histopathology, who have undergone primary or interval cytoreductive surgery and achieved CR/PR after platinum-based chemotherapy, receiving first-line maintenance therapy with a PARP inhibitor (no restriction on type). 4. The duration of maintenance therapy with a PARP inhibitor is greater than 6 months, followed by the first recurrence. 5. Known BRCA mutation status. 6. The use of Bevacizumab in first-line chemotherapy is allowed. 7. The patient's ECOG performance status is 0-1. 8. Ability to comply with subsequent treatment plans. 9. Any toxic side effects from previous chemotherapy have recovered to=CTCAE grade 1 or baseline level, except for stable sensory neuropathy or alopecia at =CTCAE grade 2.
Exclusion criteria
Exclusion criteria: 1. In the judgment of the researcher, the presence of a serious condition that endangers patient safety or affects the patient's ability to complete the study. 2. Patients with other malignant tumors who are currently using anti-cancer drugs. 3. Patients who have had other invasive cancers, except ovarian cancer, within the 2 years prior to enrollment (excluding completely treated basal or squamous cell skin cancer). 4. Patients with a past or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 5. Patients with severe or uncontrolled diseases, including but not limited to: - Severe chronic obstructive pulmonary disease with hypoxemia. - Active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc. - Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other psychiatric disorders that affect the patient's ability to provide informed consent. - Immunodeficiency (excluding splenectomy) or other conditions that the researcher believes may expose the patient to high-risk toxicity. 6. Any past or current disease, treatment, or laboratory abnormality that may interfere with study results or affect the patient's full participation in the study, or if the researcher believes the patient is unsuitable for the study. 7. Pregnant or breastfeeding patients, or those planning to become pregnant during the study treatment period. 8. Corrected QT interval (QTc) > 450 milliseconds; if the patient has a prolonged QTc interval, but the researcher assesses that the prolongation is due to a cardiac pacemaker (and there are no other cardiac abnormalities), it is necessary to discuss with the researcher to decide whether the patient is suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate of secondary cytoreduction surgery;Disease free survival;; | — |
Countries
China
Contacts
Public ContactXiaojun Chen
Fudan University Shanghai Cancer Center
Outcome results
None listed