Efficacy and Safety of Niraparib in Combination With Anlotinib Based on CA 125 Level in Newly Diagnosed Ovarian Cancer: A Open-label, Single Arm, Prospective Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Ovarian Carcinoma
- Sponsor
- Lei Li
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Progression free survival (PFS)
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a phase II trial to explore efficacy and safety of niraparib in combination with anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of 1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with CA-125 increased > 35U/ml, and with no evidence of imaging recurrence, niraparib and anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer after achieving complete or partial remission to platinum-containing chemotherapy. The primary objective of this study is to explore the efficacy of niraparib combined with anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging recurrence. A total o f36 patients will be enrolled in this study.
Investigators
Lei Li
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: 24 months
Progression free survival (PFS) by RECIST v 1.1
Secondary Outcomes
- Overall survival (OS)(48 months)
- Adverse events(24 months)
- Time to first subsequent therapy (TFST)(24 months)