Phase
Condition
Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Treatment
Paclitaxel
Carboplatin
Bevacizumab
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject voluntarily agrees to participate and signs the informed consent form.
Age ≥18 years (calculated as of the date of signing the informed consent).
Pathologically diagnosed with newly diagnosed, FIGO stage III-IV high-grade (ormoderate/low-grade) serous ovarian cancer, fallopian tube cancer, or primaryperitoneal cancer; grade ≥II endometrioid adenocarcinoma of the ovary; Mixed tumors:high-grade serous or ≥II grade endometrioid component must be >50%.
The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1).
According to the investigator's assessment, the patient is unable to achieve R0resection or cannot tolerate surgery. a) Criteria for determining inability to achieve R0 resection include: i. Fagottilaparoscopic score ≥8. ii. If laparoscopic assessment is difficult, an upperabdominal Suidan's CT score ≥3. b) Criteria for inability to tolerate surgery include: i. Body mass index (BMI) ≥40.ii. Multiple chronic diseases. iii. Malnutrition or hypoalbuminemia. iv. Moderate tolarge ascites. v. Newly diagnosed venous thromboembolism. vi. ECOG performancestatus >2. vii. Other reasons judged by the investigator.
Expected survival >12 weeks.
ECOG performance status: 0-2.
Confirmed germline BRCA1/2 mutations by professional genetic testing.
Function of major organs meets the following requirements (no blood products orcolony-stimulating factors allowed within 14 days prior to the first dose):
Absolute neutrophil count ≥1.5 × 10^9/L.
Platelet count ≥100 × 10^9/L.
Hemoglobin ≥9 g/dL.
Serum albumin ≥3 g/dL.
Bilirubin ≤1.5 times the upper limit of normal (ULN).
ALT and AST ≤2.5 times ULN, must be ≤5 times ULN in the presence of livermetastases.
Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (calculatedusing the Cockcroft-Gault formula).
Female patients of childbearing potential must have a negative blood pregnancy testwithin one week before the first dose and are not breastfeeding. They must agree touse effective contraception during the study and for 6 months after the last dose ofBevacizumab/Fluzoparib/chemotherapy. Pregnancy, if confirmed, must be terminated assoon as possible.
The subject is willing to cooperate in completing quality of life surveys during thetreatment and follow-up periods and agrees to have the survey results used forclinical research.
Exclusion
Exclusion Criteria:
Patients with other untreated malignant tumors within the past 5 years, except forcured skin basal cell carcinoma, cervical carcinoma in situ, and breast cancerwithout relapse for over 3 years after radical surgery.
Patients with untreated central nervous system metastases. Patients who havepreviously received systemic or curative brain or meningeal metastasis treatment (radiotherapy or surgery) and have stable imaging confirmed for at least 1 month,and have stopped systemic steroid treatment (dosage >10 mg/day prednisone orequivalent) for more than 2 weeks, and have no clinical symptoms, may be included.
Patients who have previously received treatment with known or potential PARPinhibitors or Bevacizumab.
Patients unable to swallow tablets or with gastrointestinal dysfunction that mayaffect drug absorption, as judged by the investigator.
Patients who have experienced bowel obstruction or gastrointestinal perforationwithin the last 3 months.
Patients with poorly controlled heart conditions or diseases, such as:
NYHA Class II or higher heart failure.
Unstable angina.
Myocardial infarction within 1 year.
Clinically significant supraventricular or ventricular arrhythmias requiringtreatment or intervention.
QTc >470 ms.
Patients with clinically significant bleeding symptoms or a clear bleeding tendency (such as gastrointestinal bleeding, bleeding ulcers, or vasculitis) within 3 monthsprior to the first dose, or with positive occult blood in the stool at baseline. Ifpositive, it should be rechecked, and if still positive, clinical judgment should bemade, including possible gastrointestinal endoscopy if necessary.
Patients who have received platelet or red blood cell transfusion within 14 daysbefore starting treatment.
Patients with active ulcers, non-healing wounds, or fractures.
Patients who have experienced any severe bleeding event graded ≥2 in CTCAE 5.0within 4 weeks before the first dose.
Patients with active infections or unexplained fever >38.5°C during screening orbefore the first dose.
Patients with congenital or acquired immune deficiency (e.g., HIV-infectedindividuals) or active hepatitis (HBV reference: HBsAg positive, HBV DNA ≥500 IU/ml;HCV reference: HCV antibody positive, HCV RNA > normal upper limit).
Patients who have previously received radiotherapy, chemotherapy, hormonal therapy,or molecular targeted therapy, with less than 4 weeks since the last dose oftreatment (less than 5 half-lives for oral molecular-targeted agents); patients whohave not recovered from treatment-related adverse events (except for hair loss) to ≤1 grade as per CTCAE 5.0.
Patients who have experienced arterial thrombosis or ≥grade 3 venous thromboembolicevents within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction),deep vein thrombosis, or pulmonary embolism.
Patients with a history of hereditary or acquired bleeding disorders or coagulationdysfunction (e.g., hemophilia, platelet dysfunction, thrombocytopenia, etc.).
Patients who may receive other systemic antitumor treatments during the studyperiod.
Patients with uncontrolled hypertension, despite antihypertensive treatment (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
Pregnant or breastfeeding women, or women planning pregnancy during the studytreatment.
Patients with other factors, as judged by the investigator, that may lead to thepremature termination of the study, such as other severe diseases (includingpsychiatric disorders) requiring concurrent treatment, severe laboratoryabnormalities, or factors related to family or social circumstances that may impactthe patient's safety, or the collection of data and samples.
Study Design
Connect with a study center
Qilu Hospital of Shandong University
Jinan, Shandong 250000
ChinaActive - Recruiting

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