Clinical trial · Observational
Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study
Real-world Data From a Multi-center Study: Insights to the Effectiveness and Safety in Patients With Ovarian Cancer Receiving Niraparib as First-line Maintenance Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In order to explore the real situation of niraparib in clinical application more comprehensively and deeply, we conducted the first multicenter, real-world study in China. This large observational study used real-world data to assess the effectiveness and safety of niraparib as maintenance therapy in patients with advanced ovarian cancer (AOC) in China and investigated clinical factors associated with prolonged benefits of niraparib so as to achieve the maximum clinical benefit of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niraparib | Drug | Niraparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy
- description
- This multi-center, observational, retrospective study collected real-world medical record data of patients with advanced ovarian cancer treated with niraparib as first-line maintenance therapy from fourteen hospitals in China. In reality, these patients received different oral doses of niraparib until disease progression, severe toxicity occurred, or death. A total of 199 patients were included in a centralized database ultimately with a median age of 57.0 years (range, 51.0-63.5 years).
- interventionNames
- Drug: Niraparib
Primary outcomes (1)
- measure
- progression-free survival(PFS)
- timeFrame
- up to 29 months
- description
- time from the date of initiation of maintenance therapy with niraparib to the date of disease progression in our study
Secondary outcomes (2)
- measure
- time to treatment discontinuation (TTD)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * diagnosed with histologically confirmed ovarian cancer (International Federation of Gynecology and Obstetrics \[FIGO\] Stage II-IV) * underwent surgery and first-line chemotherapy and were treated with niraparib as maintenance therapy * the date to start maintenance therapy with niraparib is from January 2019 to December 2021 Exclusion Criteria: * had experienced other malignancies within the previous 5 years * enrolled in clinical trials in which investigators were blinded to the treatments * with a previous or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
References
Publications (0)
Data not yet available