Albumin-bound Paclitaxel and Bevacizumab for Platinum-resistant Recurrent Epithelial Ovarian Cancer: A Single-arm, Multi-center, Phase II Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ovarian Carcinoma
- Sponsor
- Lei Li
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Lei Li
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 24 months
ORR is defined as the percentage of participants in the analysis population who have a complete or partial remission per RECIST 1.1
Secondary Outcomes
- Adverse Events(36 months)
- Progression-Free Survival (PFS)(24 months)
- Overall survival(36 months)