Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 1920
• From 1 Dec 2024 to the primary completion date, 30 May 2027
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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