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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT06241105
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 to 75 years;
2. Platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
3. According to the RECIST 1.1 criteria, there should be at least one measurable lesion or a CA 125 level of ≥ 70 IU/L.
4. ECOG 0-2；
5. Liver and Kidney Function: Serum creatinine levels should be ≤ 1.5 times the upper limit of the normal range.AST and ALT levels should be ≤ 2.5 times the upper limit of normal, or ≤ 5 times the upper limit of normal if liver metastases are present;total bilirubin should be ≤ 1.5 times the upper limit of the normal range.
6. Participants of reproductive age must consent to the use of effective contraceptive methods throughout the duration of the study.Women of reproductive age must yield a negative result in serum or urine pregnancy tests.Non-lactating patients.
7. Those who are expected to survive longer than 3 months. Patients were unconscious and volunteered to participate in the study.
Exclusion Criteria:
1. Uncontrollable malignant hypertension;
2. Imaging showed that the tumor invaded important blood vessels;
3. Contraindications to the use of antiangiogenic agents;
4. Contraindications to checkpoint inhibitors;
5. Patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess;
6. Simultaneous involvement or engagement in another clinical trial within a one-month period that could potentially influence the outcomes of this study.
7. Known hypersensitivity to study-related drugs or their excipients;
8. Individuals with severe heart, liver, kidney, and other serious concurrent diseases that may pose a threat to life;
9. Patients judged by the investigator to be inappropriate for participation in the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06241105
Study Brief:
Protocol Section:
NCT06241105