Niraparib as first-line maintenance for advanced ovarian cancer
Official title: Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer and the Establishment and Promotion of Its Standardized Application System
Run by Fudan University · NCT07783022 · Data updated 2026-11-12
This real-world, non-interventional study looks at how niraparib used as first-line maintenance works in women with advanced ovarian cancer in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1920 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | May 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07783022 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer, who achieved CR/PR after first-line platinum therapy and are receiving niraparib maintenance in clinical practice.
✕Probably not a fit
Patients not receiving niraparib maintenance or with contraindications to niraparib may not experience any benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational, real-world study evaluating niraparib as maintenance therapy after first-line platinum-based chemotherapy in eligible ovarian cancer patients. Data are collected from standard clinical practice to describe real-world efficacy, safety, and treatment patterns, including exploration of how HRD biomarkers relate to response. No experimental treatment is given; Niraparib administration follows approved labeling and individual patient conditions. The study aims to enrich practical evidence to support personalized treatment decisions in routine settings.
Why it matters
Potential benefit: If successful, findings could clarify real-world effectiveness and safety of niraparib maintenance, aiding better treatment decisions for patients and clinicians.
How similar studies have gone: Previous real-world observations with niraparib have informed practice; this study explores real-world outcomes in a specific first-line maintenance setting which adds contemporary evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Female patients aged ≥ 18 years. 2. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 3. Histological subtype of high-grade serous carcinoma or high-grade endometrioid adenocarcinoma. 4. Received only prior first-line platinum-based chemotherapy and achieved complete response (CR) or partial response (PR) to chemotherapy. 5. Patients who received niraparib maintenance therapy in clinical practice. Exclusion Criteria 1. Patients with comorbidities that, in the investigator's judgment, would seriously endanger patient safety or interfere with medication administration. 2. Patients receiving anti-tumor drugs for other concurrent malignant neoplasms. 3. Pregnant or breastfeeding patients.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.