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

Exclusion Criteria31

• 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).
• .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).
• 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).
• 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.
• \. Unintentional weight loss ≥5% within 3-6 months or presence of cachexia .
• \. 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