Eligibility |
Inclusion Criteria:
1. Females aged 18-80;
2. Histologically confirmed ovarian epithelial carcinoma;
3. Ovarian cancer patients who have failed or relapsed after first-line treatment, with
or without other treatments;
4. At least one measurable lesion according to RECIST 1.1 ;
5. Positive expression of mesothelin in ovarian cancer tumors;
6. Functional status score (KPS) =80;
7. Expected survival =28 weeks;
8. The function of important organs meets the following requirements: absolute neutrophil
count =1.5×109/L; platelets count =50×109/L; hemoglobin =80g/L; serum albumin
=2.5g/dL; bilirubin =1.5 times ULN; ALT and AST =3 times ULN; serum creatinine =1.5
times ULN;
9. Able to understand the informed consent form, voluntarily participate, and sign the
informed consent form;
10. The subject or their partner agrees to take the contraceptive measures recognized by
the trial within 1 month after signing the informed consent form until the end of the
study.
Exclusion Criteria:
1. Exclusion criteria include those who have had other malignant tumors within the past 5
years, except for those who have been cured of basal cell carcinoma, cervical
carcinoma in situ, and breast cancer that has not recurred for >3 years after radical
surgery.
2. Patients known to have central nervous system metastasis or leptomeningeal disease are
excluded.
3. Patients who have experienced arterial thromboembolic events (including myocardial
infarction, cardiac arrest, cerebrovascular accident, ischemic stroke, deep venous
thrombosis of CTCAE 5.0 grade =3) or a history of pulmonary embolism within 6 months
prior to enrollment are excluded.
4. Patients with a history of serious bleeding disorder within 6 months prior to
screening, or those with a clear tendency to bleed (such as esophageal varices at risk
of bleeding, active ulcer lesions, fecal occult blood >2+) as judged by the
investigator, are excluded.
5. Patients with congenital or acquired immunodeficiency (such as HIV infection), active
hepatitis B or C virus infection, or other severe infectious diseases are excluded.
6. Patients with clinically significant cardiovascular disease:
1. Uncontrolled hypertension (systolic blood pressure =160mmHg and/or diastolic
blood pressure =110mmHg) despite treatment;
2. History of myocardial infarction or unstable angina pectoris within 6 months
prior to enrollment;
3. Congestive heart failure or NYHA class II heart failure;
4. Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial
fibrillation that is controllable.
7. Pregnant or lactating women are excluded.
8. Those who have participated in or are currently participating in other clinical trials
within the past three months are excluded.
9. Patients considered unsuitable for this clinical trial by the investigator are
excluded.
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