Ovarian CancerNCT07783022
Real-World Study of Niraparib in First-Line Maintenance Therapy for Advanced Epithelial Ovarian Cancer
An observational study of Ovarian Cancer, run by Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Niraparib (Tablet)
- Type of treatment
- Pill or oral medicine
- How many people
- 1,920 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged ≥ 18 years with histologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (high-grade serous or high-grade endometrioid adenocarcinoma). Subjects received first-line platinum-based chemotherapy with CR/PR and niraparib first-line maintenance therapy in routine clinical practice. This is a non-interventional real-world cohort study.
Who may be able to join
- Female patients aged ≥ 18 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Histological subtype of high-grade serous carcinoma or high-grade endometrioid adenocarcinoma.
- Received only prior first-line platinum-based chemotherapy and achieved complete response (CR) or partial response (PR) to chemotherapy.
- Patients who received niraparib maintenance therapy in clinical practice.
Who cannot join
- Patients with comorbidities that, in the investigator's judgment, would seriously endanger patient safety or interfere with medication administration.
- Patients receiving anti-tumor drugs for other concurrent malignant neoplasms.
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
yanping zhong, 18021293440, z66zhongyp@163.com
About this study
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
- 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.
- 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.
- Conditions
- Ovarian Cancer
- Being tested
- Niraparib (Tablet)
- Keywords
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib (Tablet)Drug
Niraparib administered as first-line maintenance therapy per routine clinical physician prescription and approved product labeling. The study does not initiate, allocate, or modify treatment for participants.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving niraparib first-line maintenance therapy | Not described Receives: Drug: Niraparib (Tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Time from initiation of niraparib first-line maintenance therapy to disease progression (per investigator assessment) or death from any cause, whichever occurs first.
Measured: Up to 36 months after niraparib initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Dec 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Wen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783022
- Sponsor's protocol ID
- 2502-Exp139
- Status last verified
- Nov 2025
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07783022
- Acronym / sponsor ID
- 2502-Exp139
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,920 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving niraparib first-line maintenance therapy | – | Drug: Niraparib (Tablet) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged ≥ 18 years with histologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (high-grade serous or high-grade endometrioid adenocarcinoma). Subjects received first-line platinum-based chemotherapy with CR/PR and niraparib first-line maintenance therapy in routine clinical practice. This is a non-interventional real-world cohort study.
Key inclusion criteria (5 listed)
- Female patients aged ≥ 18 years.
- Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Histological subtype of high-grade serous carcinoma or high-grade endometrioid adenocarcinoma.
- Received only prior first-line platinum-based chemotherapy and achieved complete response (CR) or partial response (PR) to chemotherapy.
- Patients who received niraparib maintenance therapy in clinical practice.
Key exclusion criteria (3 listed)
- Patients with comorbidities that, in the investigator's judgment, would seriously endanger patient safety or interfere with medication administration.
- Patients receiving anti-tumor drugs for other concurrent malignant neoplasms.
- Pregnant or breastfeeding patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib (Tablet)Niraparib administered as first-line maintenance therapy per routine clinical physician prescription and approved product labeling. The study does not initiate, allocate, or modify treatment for participants. | Drug | Patients receiving niraparib first-line maintenance therapy |
Primary outcome
PFS
Time frame: Up to 36 months after niraparib initiation
Time from initiation of niraparib first-line maintenance therapy to disease progression (per investigator assessment) or death from any cause, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 36 months after niraparib initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.