Status:
RECRUITING
Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer
Lead Sponsor:
Tongji Hospital
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 c...
Eligibility Criteria
Inclusion
- 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 :
- 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
- 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).
- 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).
- Hereditary/acquired bleeding disorders (e.g., hemophilia, thrombocytopenia).
- 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
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2032
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT06954584
Start Date
May 27 2025
End Date
March 1 2032
Last Update
June 24 2025
Active Locations (2)
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1
Tongji Hospital
Wuhan, Hubei, China, 430000
2
Tongji Hospital
Wuhan, Hubei, China