Overview
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel combined with bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.
Eligibility
Inclusion Criteria
- Aged 18~75 years old
- Histologically confirmed platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Sufficient bone marrow function;
- Sufficient liver and renal function;
- Patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative serum or urine pregnancy test result; non-lactating women;
- Patients had no disturbance of consciousness and volunteered to participate in the study.
Exclusion Criteria
- Uncontrolled hypertension
- Tumor invading vital blood vessels
- With contraindications to chemotherapy
- With uncontrolled infection
- Patients had received anticancer therapy within 3 weeks before enrollment
- Patients were allergic or intolerant to investigational drugs or its ingredients
- Patients are not suitable for this trial as judged by investigators