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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (NCT06954584) is a Phase 3 interventional studying Ovarian Cancer, sponsored by Tongji Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Ovarian Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 424 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The participant voluntarily joins the study, provides written willing to sign a consent form, demonstrates good compliance, and agrees to follow-up. 2. Female, age ≥18 years (calculated on the day of signing the willing to sign a consent form form). 3. diagnosed by tissue sample (biopsy-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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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)

BEHAVIORAL

Dietary Intervention

Control carbohydrate intake in the daily diet

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tongji Hospital
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06954584), the sponsor (Tongji Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06954584 clinical trial studying?

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 diet… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06954584?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06954584?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06954584. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06954584. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.