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Can a maintenance drug extend remission in ovarian cancer? a large Real-World study investigates

NCT ID NCT07783022

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study looks at how well niraparib works as a first-line maintenance therapy for women with advanced ovarian cancer when used in everyday clinical practice. It will follow about 1,920 patients who have completed initial chemotherapy and are now taking niraparib to keep the cancer from returning. The goal is to measure how long patients stay free of progression, how safe the drug is, and how it is actually used by doctors. The findings could help refine treatment strategies and support more personalized care for ovarian cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
niraparib
What this could lead to
If successful, this study could provide stronger evidence for using niraparib as a standard first-line maintenance treatment, potentially improving outcomes for many ovarian cancer patients.
What could go wrong
As a real-world, non-interventional study, it cannot prove cause and effect, and results may be influenced by patient differences and treatment variations. Side effects of niraparib, such as fatigue and low blood counts, are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,920 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fallopian tube cancer ovarian cancer ovarian carcinoma primary peritoneal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

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