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New treatment option for Ovarian Cancer
Official title Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
ClinicalTrials.gov ID: NCT06735326
What this study is testing
What is Fluzoparib?
Fluzoparib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, open-label, multi-cohort, multicenter clinical trial, aimed at evaluating the efficacy and safety of Fluzoparib monotherapy, Fluzoparib in combination with Bevacizumab, and standard chemotherapy (Paclitaxel plus Carboplatin) as neoadjuvant treatments in newly diagnosed, germline BRCA1/2-mutated epithelial ovarian cancer patients (FIGO stage III/IV). The study also aims to assess the efficacy and safety of Fluzoparib as maintenance therapy following surgery and chemotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 (or moderate/low-grade) serous ovarian cancer, fallopian tube cancer, or...
- 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 R0 resection or cannot tolerate surgery. a) Criteria for determining...
You likely can't join if
- Patients with other untreated malignant tumors within the past 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and...
- Patients with untreated central nervous system metastases. Patients who have previously received systemic or curative brain or meningeal metastasis...
- Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab.
- Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator.
- Patients who have experienced bowel obstruction or gastrointestinal perforation within the last 3 months.
- Patients with poorly controlled heart conditions or diseases, such as:
See the full eligibility criteria
Who can join
- 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 (or moderate/low-grade) serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; grade ≥II endometrioid adenocarcinoma of...
- 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 R0 resection or cannot tolerate surgery. a) Criteria for determining inability to achieve R0 resection include: i. Fagotti laparoscopic score...
- 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 or colony-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 liver metastases.
- Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula).
- Female patients of childbearing potential must have a negative blood pregnancy test within one week before the first dose and are not breastfeeding. They must agree to use effective contraception during the study and...
- The subject is willing to cooperate in completing quality of life surveys during the treatment and follow-up periods and agrees to have the survey results used for clinical research.
What rules you out
- Patients with other untreated malignant tumors within the past 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and breast cancer without relapse for over 3 years after radical surgery.
- Patients with untreated central nervous system metastases. Patients who have previously received systemic or curative brain or meningeal metastasis treatment (radiotherapy or surgery) and have stable imaging confirmed...
- Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab.
- Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator.
- Patients who have experienced bowel obstruction or gastrointestinal perforation within 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 requiring treatment 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 months prior to the first dose, or with positive occult...
- Patients who have received platelet or red blood cell transfusion within 14 days before starting treatment.
- Patients with active ulcers, non-healing wounds, or fractures.
- Patients who have experienced any severe bleeding event graded ≥2 in CTCAE 5.0 within 4 weeks before the first dose.
- Patients with active infections or unexplained fever \>38.5°C during screening or before the first dose.
- Patients with congenital or acquired immune deficiency (e.g., HIV-infected individuals) or active hepatitis (HBV reference: HBsAg positive, HBV DNA ≥500 IU/ml; HCV reference: HCV antibody positive, HCV RNA \> normal...
- Patients who have previously received radiotherapy, chemotherapy, hormonal therapy, or molecular targeted therapy, with less than 4 weeks since the last dose of treatment (less than 5 half-lives for oral...
- Patients who have experienced arterial thrombosis or ≥grade 3 venous thromboembolic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral...
- Patients with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, platelet dysfunction, thrombocytopenia, etc.).
- Patients who may receive other systemic antitumor treatments during the study period.
- 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 study treatment.
- Patients with other factors, as judged by the investigator, that may lead to the premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concurrent treatment, severe...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.