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Ovarian CancerPhase 3NCT06954584

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

A Phase 3 study testing Bevacizumab, Fluzoparib Monotherapy and Dietary Intervention in people with Ovarian Cancer, run by Tongji Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Cancer
What is being tested?
Bevacizumab, Fluzoparib Monotherapy and Dietary Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
2 sitesChina
Study dates
27 May 2025to 1 Mar 2032
Phase
Phase 3
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The participant voluntarily joins the study, provides written informed consent, demonstrates good compliance, and agrees to follow-up.
  • Female, age ≥18 years (calculated on the day of signing the informed consent form).
  • 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% .
  • FIGO 2018 staging as Stage III or IV .
  • Documented HRD (Homologous Recombination Deficiency) test results .
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  • 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 .
  • 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.
  • ECOG Performance Status (PS) : 0-1.
  • 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).

Who cannot join

  • 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).
  • 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.
  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting

  • Tongji Hospital

    Wuhan, Hubei, 430000

    Qinglei Gao, 027-83663131, qingleigao@hotmail.com

    Recruiting

  • Tongji Hospital

    Wuhan, Hubei

    Qinglei Gao, 027-83663131, qingleigao@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Conditions
Ovarian Cancer
Being tested
Bevacizumab, Fluzoparib Monotherapy, Dietary Intervention
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Bevacizumab : 15 mg/kg intravenously every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 15 months

  • Fluzoparib MonotherapyDrug

    150 mg orally bid (50 mg/capsule, 3 capsules/dose)

  • Dietary InterventionBehavioural

    Control carbohydrate intake in the daily diet

Study groups in NCT06954584
Study groupRoleWhat they receive
HRD-Positive Cohort (Experimental Group): Fluzoparib + BevacizumabExperimentalFluzoparib 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 .
Receives: Drug: Bevacizumab; Drug: Fluzoparib Monotherapy
HRD-Positive Cohort (Control Group): Fluzoparib MonotherapyActive comparatorFluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Receives: Drug: Fluzoparib Monotherapy
HRD-Negative Cohort (Experimental Group 1): Fluzoparib + Dietary InterventionExperimentalFluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Receives: Drug: Fluzoparib Monotherapy; Behavioral: Dietary Intervention
HRD-Negative Cohort (Experimental Group 2): Fluzoparib MonotherapyExperimentalFluzoparib Capsules : 150 mg orally bid (50 mg/capsule, 3 capsules/dose)
Receives: Drug: Fluzoparib Monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    The time from randomization to the occurrence of disease progression (as per RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: 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 outcomes (5)

  1. Time to Progression (TTP)

    The time from randomization to CA125 progression (as per GCIG-CA125 criteria) or disease progression (as per RECIST criteria), whichever occurs first.

    Measured: 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

  2. Time to Discontinuation or Death (TDT)

    The time from randomization to discontinuation of study treatment or death from any cause, whichever occurs first.

    Measured: 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

  3. ime to First Subsequent Therapy (TFST)

    The time from randomization to the initiation of subsequent anti-tumor therapy for ovarian cancer, or death.

    Measured: 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

  4. Best Overall Response (BOR)

    The best objective response recorded from randomization until disease progression or recurrence.

    Measured: From date of randomization until disease progression or recurrence, assessed up to 96 months

  5. Overall Survival (OS)

    The time from randomization to death due to any cause.

    Measured: From date of randomization until the date of death from any cause, assessed up to 96 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2025
  2. Study start27 May 2025
  3. Primary completion1 May 2030 (estimated)
  4. Study completion1 Mar 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06954584
Sponsor's protocol ID
MA-OC-III-013
Status last verified
Jun 2025
First submitted
13 Apr 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Fluzoparib Monotherapy and Dietary Intervention in people with Ovarian Cancer, run by Tongji Hospital at 2 sites 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 30 inclusion and 32 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 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06954584.

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 Jun 2025.

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