Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT05819060
Eligibility Criteria:
Inclusion Criteria:
1. Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;
2. Patients who have previously received platinum-based chemotherapy and had a recurrence interval of \> 6 months before the last platinum-based chemotherapy;
3. Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;
4. Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;
5. The patient achieved a complete or partial response after the last platinum-based chemotherapy;
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
7. The patient has a life expectancy of at least 3 months and sufficient organ function;
8. The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;
9. The patient voluntarily agrees to participate in this study and signs an informed consent form.
Exclusion Criteria:
1. Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;
2. Patients who have undergone major surgery within 28 days prior to enrollment;
3. Patients with central nervous system metastases or a history of seizures within the past 12 months;
4. Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;
5. NYHA functional class ≥ III;
6. Patients with severe, uncontrolled systemic diseases;
7. Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;
8. Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;
9. Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;
10. Patients judged by the investigator to be unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05819060
Study Brief:
Protocol Section:
NCT05819060