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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer

A Randomized, Open-Label, Multi-Cohort Study of Fluzoparib Monotherapy or in Combination With Bevacizumab as Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer

Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer (NCT06735326) is a Phase 2 interventional studying Ovarian Cancer and Fallopian Tube Cancer, sponsored by Qilu Hospital of Shandong University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. The primary endpoint of the study is the objective response rate (ORR) for neoadjuvant therapy, as assessed by the investigator using RECIST v1.1 criteria. Secondary endpoints include R0 resection rate, overall survival (OS), and progression-free survival (PFS). The study will also evaluate the safety, tolerability, and patient-reported outcomes (EQ-5D-5L) across the three treatment cohorts.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 105 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ovarian Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The subject voluntarily agrees to participate and signs the willing to sign a consent form form. 2. Age ≥18 years (calculated as of the date of signing the willing to sign a consent form). 3. 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 ovary; Mixed tumors: high-grade serous or ≥II grade endometrioid component must be \>50%. 4. The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1). 5. 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 ≥8. ii. If laparoscopic assessment is difficult, an upper abdominal 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 to large ascites. v. Newly diagnosed venous thromboembolism. vi. ECOG performance status \>2. vii. Other reasons judged by the investigator. 6. Expected survival \>12 weeks. 7. ECOG performance status: 0-2. 8. Confirmed germline BRCA1/2 mutations by professional genetic testing. 9. Function of major organs meets the following requirements (no blood products or colony-stimulating factors allowed within 14 days prior to the first dose): 1. Absolute neutrophil count ≥1.5 × 10\^9/L. 2. Platelet count ≥100 × 10\^9/L. 3. blood count (hemoglobin) at least 9 g/dL. 4. Serum albumin ≥3 g/dL. 5. Bilirubin ≤1.5 times the upper limit of normal (ULN). 6. ALT and AST ≤2.5 times ULN, must be ≤5 times ULN in the presence of liver metastases. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. The subject voluntarily agrees to participate and signs the informed consent form. 2. Age ≥18 years (calculated as of the date of signing the informed consent). 3. 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 ovary; Mixed tumors: high-grade serous or ≥II grade endometrioid component must be \>50%. 4. The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1). 5. 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 ≥8. ii. If laparoscopic assessment is difficult, an upper abdominal 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 to large ascites. v. Newly diagnosed venous thromboembolism. vi. ECOG performance status \>2. vii. Other reasons judged by the investigator. 6. Expected survival \>12 weeks. 7. ECOG performance status: 0-2. 8. Confirmed germline BRCA1/2 mutations by professional genetic testing. 9. Function of major organs meets the following requirements (no blood products or colony-stimulating factors allowed within 14 days prior to the first dose): 1. Absolute neutrophil count ≥1.5 × 10\^9/L. 2. Platelet count ≥100 × 10\^9/L. 3. Hemoglobin ≥9 g/dL. 4. Serum albumin ≥3 g/dL. 5. Bilirubin ≤1.5 times the upper limit of normal (ULN). 6. ALT and AST ≤2.5 times ULN, must be ≤5 times ULN in the presence of liver metastases. 7. Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula). 10. 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 for 6 months after the last dose of Bevacizumab/Fluzoparib/chemotherapy. Pregnancy, if confirmed, must be terminated as soon as possible. 11. 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. Exclusion Criteria: 1. 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. 2. 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 for at least 1 month, and have stopped systemic steroid treatment (dosage \>10 mg/day prednisone or equivalent) for more than 2 weeks, and have no clinical symptoms, may be included. 3. Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab. 4. Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator. 5. Patients who have experienced bowel obstruction or gastrointestinal perforation within the last 3 months. 6. Patients with poorly controlled heart conditions or diseases, such as: 1. NYHA Class II or higher heart failure. 2. Unstable angina. 3. Myocardial infarction within 1 year. 4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 5. QTc \>470 ms. 7. 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 blood in the stool at baseline. If positive, it should be rechecked, and if still positive, clinical judgment should be made, including possible gastrointestinal endoscopy if necessary. 8. Patients who have received platelet or red blood cell transfusion within 14 days before starting treatment. 9. Patients with active ulcers, non-healing wounds, or fractures. 10. Patients who have experienced any severe bleeding event graded ≥2 in CTCAE 5.0 within 4 weeks before the first dose. 11. Patients with active infections or unexplained fever \>38.5°C during screening or before the first dose. 12. 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 upper limit). 13. 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 molecular-targeted agents); patients who have not recovered from treatment-related adverse events (except for hair loss) to ≤1 grade as per CTCAE 5.0. 14. 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 hemorrhage, cerebral infarction), deep vein thrombosis, or pulmonary embolism. 15. Patients with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, platelet dysfunction, thrombocytopenia, etc.). 16. Patients who may receive other systemic antitumor treatments during the study period. 17. Patients with uncontrolled hypertension, despite antihypertensive treatment (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg). 18. Pregnant or breastfeeding women, or women planning pregnancy during the study treatment. 19. 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 laboratory abnormalities, or factors related to family or social circumstances that may impact the patient's safety, or the collection of data and samples.

Treatments Being Tested

DRUG

Fluzoparib

Fluzoparib capsule (50mg per capsule) 150mg po BID

DRUG

Bevacizumab

Bevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W

DRUG

Paclitaxel

Paclitaxel injection 135-175mg/㎡ ivdrip Q3W

DRUG

Carboplatin

Carboplatin injection AUC=4-5 ivdrip Q3W

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Qilu Hospital of Shandong University
Jinan, Shandong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06735326), the sponsor (Qilu Hospital of Shandong University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06735326 clinical trial studying?

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. The primary endpoint of the study is the objective response rate (ORR) for neoadjuvant thera… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06735326?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06735326?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06735326. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06735326. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.