Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer
Conditions
Interventions
Patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:Lucentis in combination with bevacizumab
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study and signed the informed consent; 2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; 3.Patients with platinum-resistant recurrence, defined as disease progression occurring during the most recent platinum-containing chemotherapy regimen or within 6 months after the last dose of platinum-containing chemotherapy. After confirmation of platinum drug resistance, subjects are allowed to receive subsequent other non-platinum treatment regimens; 4. Age range: 18-75 years old; 5. Patients with objective measurable lesions according to RECIST 1.1 criteria; 6. ECOG score of 0-1; 7. Expected survival of more than 3 months; 8. The time since the last use of bevacizumab is >=6 months; 9. The main organ functions are normal, which meets the following criteria: absolute neutrophil count >= 1.5×10^9, platelets >= 100×10^9, hemoglobin >= 90g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5×upper normal limit (UNL), total bilirubin < 1.5×UNL, serum creatinine < 1.5×UNL; 10. Subjects with potential fertility need to use at least one medically approved contraceptive method (such as intrauterine devices, contraceptives, or condoms) during the study treatment period and within 180 days after the end of the study treatment period; and the serum/urine HCG test must be negative before the first dose; and they must not be breastfeeding.
Exclusion criteria
Exclusion criteria: 1. Patients with histopathological diagnosis of mucinous adenocarcinoma; 2. Known allergies to any of the drugs in the study; 3. History of severe cardiovascular and cerebrovascular diseases: • Cerebrovascular accident (excluding lacunar stroke) within 6 months before the first administration of the study drug cerebral infarction, minor cerebral ischemia or transient ischemic attack), myocardial infarction, unstable angina pectoris, poorly controlled arrhythmias (including QTc interval >= 450 ms in males and >= 470 ms in females) (QTc interval is calculated using the Fridericia formula); • NYHA heart function classification > II or left ventricular ejection fraction (LVEF) = 140 mmHg or diastolic blood pressure >= 90 mmHg); 7. Within 28 days before the first administration of the study drug, the subject has undergone major surgery. The definition of major surgery in this study is: surgery that requires at least 3 weeks of recovery time before the subject can receive treatment in this study; 8. Urine routine test indicates that the urine protein is >=++ and the 24-hour urine protein quantity is confirmed to be >1.0g; 9. Pleural effusion, pericardial effusion or ascites that cannot be controlled after appropriate intervention; 10. History of other malignant tumors within five years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin; 11. HIV positive; 12. Symptomatic brain metastasis (confirmed or suspected); 13. The researcher believes that the subject has any clinical or laboratory abnormalities or other reasons that make them unsuitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Analysis;Disease control rate;Progression-free survival;Overall survival;Duration of relief; | — |
Countries
China
Contacts
Public ContactChunyan Lan
Sun Yat-sen University Cancer Center
Outcome results
None listed