Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer

June 17, 2025 updated by: Qinglei Gao, Tongji Hospital

An Open-label, Randomized Controlled, Multicenter Study With Dual HRD-positive/Negative Cohorts Evaluating Fluzoparib Monotherapy Versus Combination Therapy With Bevacizumab or Dietary Intervention as Maintenance Treatment Following First-line Platinum-based Chemotherapy in Advanced Ovarian Cancer

Fluzoparib has been approved for the first-line maintenance treatment of advanced ovarian cancer in the full population . Previous studies have demonstrated that anti-angiogenic agents enhance tumor cell sensitivity to PARP inhibitors . In vitro evidence suggests that low-carbohydrate culture conditions may restore PARP inhibitor sensitivity in HRD-negative tumor cells. This study aims to validate the survival benefits of fluzoparib combined with bevacizumab in HRD-positive ovarian cancer patients during first-line maintenance therapy and explore the efficacy of fluzoparib combined with a dietary intervention in HRD-negative populations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
424

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
      • Wuhan, Hubei, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. The participant voluntarily joins the study, provides written informed consent, demonstrates good compliance, and agrees to follow-up.
  2. Female, age ≥18 years (calculated on the day of signing the informed consent form).

  3. Histologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer ; endometrioid adenocarcinoma of the ovary (grade ≥II) :

    For mixed tumors: The high-grade serous or grade ≥II endometrioid component must exceed 50% .

  4. FIGO 2018 staging as Stage III or IV .
  5. Documented HRD (Homologous Recombination Deficiency) test results .

  6. Completed platinum-based chemotherapy with the following requirements:

    • Patients unable to tolerate chemotherapy for definitive reasons must complete at least 4 cycles of platinum-based chemotherapy .
    • Patients undergoing interval debulking surgery must complete at least 3 cycles of platinum-based chemotherapy post-surgery .

  7. Prior to randomization, patients must have no evidence of disease (NED) or achieve complete response (CR) or partial response (PR) after first-line platinum-based chemotherapy, with response maintained until study treatment initiation. Randomization and treatment must begin within 8 weeks after the last chemotherapy dose .

    -CR definition : No radiologic evidence of disease and CA125 ≤ upper limit of normal (ULN).

    -PR definition : ≥30% reduction in tumor size compared to pre-chemotherapy or CA125 reduction ≥90% from baseline (if imaging shows no lesions but CA125 remains above ULN).

    -For patients achieving NED after initial debulking surgery:CA125 must decrease to <1×ULN during treatment and remain <1×ULN within 7 days prior to randomization; or CA125 reduction ≥90% from baseline and no >10% increase within 7 days prior to randomization.

    -Prohibited during/after platinum-based chemotherapy : Concurrent use of other investigational drugs (except endocrine therapy) or treatments.

    -Permitted during chemotherapy : Bevacizumab combination therapy.

  8. ECOG Performance Status (PS) : 0-1.

  9. Adequate organ function (no blood transfusions or growth factors within 14 days prior to randomization):

    -Absolute neutrophil count (ANC) ≥1.5×10⁹/L.

    -Platelets ≥90×10⁹/L.

    -Hemoglobin ≥9 g/dL.

    -Serum albumin ≥3 g/dL.

    -Total bilirubin ≤1.5×ULN.

    -ALT and AST ≤2.5×ULN.

    • Serum creatinine ≤1.5×ULN.

      1 0.For women of childbearing potential :

    • Negative serum pregnancy test within 72 hours prior to randomization.
    • Agreement to use medically approved contraception during treatment and for 6 months after the last dose .
    • Non-lactating.

    Additional Inclusion Criteria for HRD-Negative Cohort Only :

11. Baseline body mass index (BMI) ≥18.5 kg/m² (BMI = weight [kg]/height [m]²).

Exclusion Criteria:

  1. History of other untreated or active malignancies within 5 years (except cured thyroid cancer, basal cell carcinoma, cervical carcinoma in situ, or breast cancer with >3 years of recurrence-free survival after radical surgery).

  2. Untreated central nervous system (CNS) metastases :

    -Patients with stable CNS metastases (confirmed by imaging for ≥1 month) after prior systemic/local therapy (e.g., surgery/radiotherapy) and off steroids (>10 mg/day prednisone equivalent) for >2 weeks may be eligible.

  3. Prior use of PARP inhibitors (e.g., olaparib, niraparib, rucaparib, pamiparib, fluzoparib).

4 .Inability to swallow tablets or gastrointestinal dysfunction affecting drug absorption (per investigator judgment).

5.Bowel obstruction or gastrointestinal perforation within 3 months prior to randomization.

6.Symptomatic malignant ascites/pleural effusion requiring drainage or drainage within 3 months prior to randomization.

7.Poorly controlled cardiac disease :

  • NYHA Class ≥II heart failure.
  • Unstable angina.
  • Myocardial infarction within 1 year.
  • Clinically significant arrhythmias requiring treatment.
  • QTc interval >470 ms. 8.Coagulation abnormalities :
  • INR >1.5 or PT >ULN +4 seconds.

  • Bleeding tendency or current use of thrombolytics/anticoagulants (low-dose LMWH or aspirin prophylaxis permitted).

    9.Clinically significant bleeding within 3 months prior to randomization (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis).

  • If baseline fecal occult blood test is positive, retesting is required. Persistent positivity may necessitate endoscopy.

    10.Active ulcers, unhealed wounds, or fractures . 11.Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg despite medication).

    1 2.Grade ≥2 bleeding events (per CTCAE v5.0) within 4 weeks prior to randomization.

    13.Active infection or unexplained fever >38.5°C during screening/prior to randomization.

    14.Immunodeficiency or active hepatitis :

  • HIV-positive.

  • Active HBV (HBsAg+ and HBV DNA ≥500 IU/mL) or HCV (HCV Ab+ and HCV RNA >ULN).

    1 5.Recent anticancer therapy :

  • Chemotherapy, radiotherapy, hormonal therapy, or targeted therapy within 4 weeks prior to study treatment (or 5 half-lives for oral targeted agents).

  • Residual toxicity from prior therapy >Grade 1 (CTCAE v5.0; alopecia excluded). 16.Arterial/venous thromboembolism within 6 months prior to randomization (e.g., stroke, transient ischemic attack, DVT, pulmonary embolism).

    17.Hereditary/acquired bleeding disorders (e.g., hemophilia, thrombocytopenia).

    18.Planned use of other systemic anticancer therapies during the study. 19.Any condition that, per investigator judgment, may lead to premature study termination.

Additional Exclusion Criteria for HRD-Negative Cohort Only :

20. Unintentional weight loss ≥5% within 3-6 months or presence of cachexia .

21. Nutritional risk :

-NRS2002 score ≥3 or need for nutritional support. 22.Diabetes requiring insulin or insulin secretagogues . 23.Acute liver disease/dysfunction . 24.Active chronic or acute kidney disease/dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HRD-Positive Cohort (Experimental Group): Fluzoparib + Bevacizumab

Fluzoparib Capsules : 150 mg orally twice daily (bid) (50 mg/capsule, 3 capsules/dose) .

Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months .
Drug: Bevacizumab
Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months
Drug: Fluzoparib Monotherapy
150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Active Comparator: HRD-Positive Cohort (Control Group): Fluzoparib Monotherapy
Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Drug: Fluzoparib Monotherapy
150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Experimental: HRD-Negative Cohort (Experimental Group 1): Fluzoparib + Dietary Intervention
Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Drug: Fluzoparib Monotherapy
150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Behavioral: Dietary Intervention
Control carbohydrate intake in the daily diet
Experimental: HRD-Negative Cohort (Experimental Group 2): Fluzoparib Monotherapy
Fluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Drug: Fluzoparib Monotherapy
150 mg orally bid (50 mg/capsule, 3 capsules/dose)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months
The time from randomization to the occurrence of disease progression (as per RECIST v1.1) or death from any cause, whichever occurs first.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Progression (TTP)
Time Frame: From date of randomization until the date of first documented CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever came first, assessed up to 96 months
The time from randomization to CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever occurs first.
From date of randomization until the date of first documented CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever came first, assessed up to 96 months
Time to Discontinuation or Death (TDT)
Time Frame: From date of randomization until the date of first documented discontinuation of study treatment or death from any cause, whichever came first, assessed up to 96 months
The time from randomization to discontinuation of study treatment or death from any cause, whichever occurs first.
From date of randomization until the date of first documented discontinuation of study treatment or death from any cause, whichever came first, assessed up to 96 months
ime to First Subsequent Therapy (TFST)
Time Frame: From date of randomization until the date of first documented initiation of subsequent anti-tumor therapy for ovarian cancer, or death, assessed up to 96 months
The time from randomization to the initiation of subsequent anti-tumor therapy for ovarian cancer, or death.
From date of randomization until the date of first documented initiation of subsequent anti-tumor therapy for ovarian cancer, or death, assessed up to 96 months
Best Overall Response (BOR)
Time Frame: From date of randomization until disease progression or recurrence, assessed up to 96 months
The best objective response recorded from randomization until disease progression or recurrence.
From date of randomization until disease progression or recurrence, assessed up to 96 months
Overall Survival (OS)
Time Frame: From date of randomization until the date of death from any cause, assessed up to 96 months
The time from randomization to death due to any cause.
From date of randomization until the date of death from any cause, assessed up to 96 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MA-OC-III-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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