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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

424

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

May 27, 2025

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

April 13, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Ovarian Cancer

Clinical Trials on Bevacizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe