This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus 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. The total treatment periods are no more than 6 cycles. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
During the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity.
Lei Li
Beijing, Beijing Municipality, China
RECRUITINGObjective Response Rate
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Time frame: 12 months
Progression-free survival (PFS)
PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.
Time frame: 12 months
Overall survival
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Time frame: 24 months
Adverse Events
Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Time frame: 24 months
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