Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer
NCT05310344 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-04-04
Summary
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.
Conditions
- Ovarian Carcinoma
- Platinum-resistant Ovarian Cancer
- Recurrent Ovarian Carcinoma
- Albumin-bound Paclitaxel
- Bevacizumab
- Survival Outcomes
- Adverse Events
Interventions
- COMBINATION_PRODUCT
-
Albumin-bound paclitaxel and bevacizumab
Patients 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.
Sponsors & Collaborators
-
Lei Li
lead OTHER
Principal Investigators
-
Lei Li, M.D. · Peking Union Medical College Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-27
- Primary Completion
- 2023-03-27
- Completion
- 2024-03-27
Countries
- China
Study Locations
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