Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
1. Study Introduction This non-interventional real-world study enrolls patients with ovarian cancer who receive niraparib as first-line maintenance therapy under routine clinical care. All patients receive physician-prescribed standard treatment without any study intervention. The administration of niraparib and concomitant medications is performed in accordance with the approved product labeling and individual clinical conditions. This study collects and analyzes real-world data concerning medication use, clinical efficacy and safety outcomes. It aims to evaluate the real-world efficacy, safety and treatment patterns of niraparib first-line maintenance therapy and explore the correlation between HRD-related biomarkers and clinical response. The results will enrich evidence-based data and support individualized optimal treatment strategies for ovarian cancer patients. 2. Study Objectives 2.1 Primary Objective To evaluate the real-world efficacy of niraparib as first-line maintenance therapy in patients with advanced epithelial ovarian cancer, based on progression-free survival (PFS), chemotherapy-free interval (CFI), time to first subsequent therapy (TFST), and overall survival (OS). 2.2 Secondary Objectives First, to evaluate the real-world safety of niraparib first-line maintenance therapy by assessing adverse events (AEs) and serious adverse events (SAEs). Second, to characterize real-world treatment patterns of niraparib, including patient baseline characteristics, initial dose, time interval from chemotherapy completion to maintenance initiation, dose adjustment, treatment interruption or discontinuation and relevant reasons, as well as concomitant and combination treatments. 2.3 Exploratory Objective To explore the association between homologous recombination deficiency (HRD)-related biomarkers and therapeutic efficacy of niraparib first-line maintenance therapy in real-world settings.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobieta w wieku 18 lat lub starszej
- •Potwierdzony histologicznie rak jajnika, jajnowodu lub otrzewnej
- •Wysokokawalikowy rak typu surowiczego lub ziarnisty
- •Wcześniej przyjmowana tylko pierwsza linia chemioterapii na bazie platyny z całkowitą lub częściową odpowiedzią
- •Aktualnie przyjmuje nirapariб jako leczenie podtrzymujące
✗ Disqualifies
- •Poważne choroby towarzyszące zagrażające bezpieczeństwu pacjentki
- •Stosowanie innych leków przeciwnowotworowych z powodu innego nowotworu
- •Ciąża lub karmienie piersią
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China
Trial contact
yanping zhong
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/25/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.