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

Recruiting now · Phase 3

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06954584

Run by

Tongji Hospital

People needed

424

Starts

2025-05-27

Expected to finish

2032-03-01

Last updated by the study team

2025-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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 .
• 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 :

You may not qualify if…

• 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).
• Bowel obstruction or gastrointestinal perforation within 3 months prior to randomization.
• Symptomatic malignant ascites/pleural effusion requiring drainage or drainage within 3 months prior to randomization.
• 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).
• 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.
• 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.
• Active infection or unexplained fever >38.5°C during screening/prior to randomization.
• 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).

Where it is running

• Tongji Hospital — Wuhan, Hubei, China (enrolling)
• Tongji Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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