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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Fluzoparib Neoadjuvant Therapy for Ovarian Cancer

A Multicenter, Single-Arm Clinical Study of Fluzoparib Monotherapy As Neoadjuvant Treatment for Advanced Epithelial Ovarian Cancer

Fluzoparib Neoadjuvant Therapy for Ovarian Cancer (NCT06541314) is a Phase 2 interventional studying Ovarian 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 an interventional, single-arm, open-label clinical trial. To evaluate the safety and efficacy of Fluzoparib as neoadjuvant therapy in patients with FIGO stage III and IV , BRCA mutations or HRD positive epithelial ovarian cancer who cannot achieve R0 surgery as assessed by imaging (Suidan's CT score) or laparoscopy (Fagotti score), or cannot tolerate surgery.

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.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Female patients aged 18-75 years. 2. Biopsies obtained via open surgery, laparoscopic surgery, or needle biopsy, confirmed by professional pathologists as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer); FIGO stage III-IV. 3. Presence of BRCA1/2 mutation or HRD positivity confirmed in tissue or blood samples by the designated testing institution of the study center. 4. Before any trial procedures begin, an willing to sign a consent form form must be signed according to the principle of willing to sign a consent form and filed at the study center. 5. The patient must have at least one measurable lesion that can be assessed by CT or MRI (RECIST 1.1). 6. Blood and tissue samples from patients can be obtained before, during, and after treatment, and subjects agree to submit blood and tissue samples to the central laboratory for the purpose of expansion research for this trial, including but not limited to: (1) possible gene-related research; (2) Possible tumor marker-related research. 7. Patients deemed unable to achieve R0 cytoreduction or unable to tolerate surgery by gynecologic oncologists at the study center: (1) Fagotti laparoscopic score ≥ 8 points; (2) When laparoscopic assessment is difficult to perform, an upper abdominal CT score ≥ 3 points may be used. Criteria for determining inability to tolerate surgery may include: (1) BMI ≥ 40.0; (2) Multiple chronic diseases; (3) Malnutrition or hypoproteinemia; (4) Moderate to large amounts of ascites; (5) Newly diagnosed venous thromboembolism; (6) ECOG \> 2. 8. Expected survival time \> 12 weeks. 9. Patients with an ECOG score of 0-2. ...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. Female patients aged 18-75 years. 2. Biopsies obtained via open surgery, laparoscopic surgery, or needle biopsy, confirmed by professional pathologists as high-grade serous or endometrioid ovarian cancer, peritoneal cancer, or fallopian tube cancer (hereinafter referred to as ovarian cancer); FIGO stage III-IV. 3. Presence of BRCA1/2 mutation or HRD positivity confirmed in tissue or blood samples by the designated testing institution of the study center. 4. Before any trial procedures begin, an informed consent form must be signed according to the principle of informed consent and filed at the study center. 5. The patient must have at least one measurable lesion that can be assessed by CT or MRI (RECIST 1.1). 6. Blood and tissue samples from patients can be obtained before, during, and after treatment, and subjects agree to submit blood and tissue samples to the central laboratory for the purpose of expansion research for this trial, including but not limited to: (1) possible gene-related research; (2) Possible tumor marker-related research. 7. Patients deemed unable to achieve R0 cytoreduction or unable to tolerate surgery by gynecologic oncologists at the study center: (1) Fagotti laparoscopic score ≥ 8 points; (2) When laparoscopic assessment is difficult to perform, an upper abdominal CT score ≥ 3 points may be used. Criteria for determining inability to tolerate surgery may include: (1) BMI ≥ 40.0; (2) Multiple chronic diseases; (3) Malnutrition or hypoproteinemia; (4) Moderate to large amounts of ascites; (5) Newly diagnosed venous thromboembolism; (6) ECOG \> 2. 8. Expected survival time \> 12 weeks. 9. Patients with an ECOG score of 0-2. 10. Good organ function. (1) Bone marrow function: NEUT ≥ 1.5\*10\^9/L; PLT ≥ 100\*10\^9/L; HGB ≥ 100g/L. (2) Liver function: TBIL ≤ 1.5 times the upper limit of normal or DBIL ≤ 1.0 times the upper limit of normal; AST and ALT ≤ 2.5 times the upper limit of normal, and in the presence of liver metastasis, must be ≤ 5 times the upper limit of normal. (3) Renal function: serum creatinine ≤ 1.5 times the upper limit of normal, or creatinine clearance rate ≥ 60 mL/min (calculated using the Cockcroft-Gault formula). 11. For women of reproductive age, a negative blood or urine pregnancy test within one week prior to enrollment is required, and effective contraceptive measures must be taken after enrollment, such as using physical barrier methods (condoms) or complete abstinence. The use of oral, injectable, or implantable hormonal contraceptives is not permitted. Or women who are not of reproductive age, defined as those who have naturally entered menopause and have been amenorrheic for over a year, have undergone surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy), or have serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels within the menopausal range as specified by the study center laboratory. 12. Understand the trial process and voluntarily sign the informed consent form, with the ability to comply with the trial protocol for the duration of the study, including cooperating with any required treatments, examinations, tests, follow-ups, and questionnaires. 13. Patients are willing to complete quality of life questionnaires during the trial treatment and follow-up process, and agree that the results of these questionnaires may be used for clinical research. 14. Any prior chemotherapy-related toxicities must have resolved to ≤ CTCAE grade 1 or baseline levels, except for stable grade 2 or lower sensory neuropathy or alopecia. Exclusion Criteria: 1. Concurrent use of other investigational drugs or participation in other clinical drug trials during this study. 2. Concurrent use of other neoadjuvant treatments for cancer during this study, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other experimental therapies. 3. Known allergy to Fluzoparib or any active or inactive components with a similar chemical structure to Fluzoparib. 4. Unable to swallow oral medications, and having any gastrointestinal disorders that may interfere with the absorption or metabolism of the study drug, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption. 5. Received any cancer-related treatment for ovarian cancer. 6. Previously received known or potential PARP inhibitor therapy. 7. Symptomatic or uncontrollable brain metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression. 8. History of severe venous thrombosis or pulmonary embolism. 9. Received other molecular targeted therapy within 4 weeks before enrollment. 10. Symptomatic or uncontrollable brain metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression. 11. Undergone major surgery within 3 weeks before the start of the study, or not yet recovered from surgery. 12. Presence of uncorrected electrolyte disturbances at the time of dosing. 13. Subjects have had other malignant diseases in the past 3 years, except for effectively treated skin squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ. 14. Patients have a history of or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 15. Patients with severe, uncontrolled diseases or whom the investigator judges to be generally unsuitable for inclusion in the study, including but not limited to: active viral infections such as human immunodeficiency virus, hepatitis B, hepatitis C, etc.; severe cardiovascular diseases, uncontrolled ventricular arrhythmias, myocardial infarction within the last 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders that may affect the patient's ability to sign the informed consent; uncontrolled hypertension; immunodeficiency (excluding splenectomy) or other conditions that the investigator considers may expose the patient to high-risk toxicity. 16. Any medical history or existing clinical evidence suggesting potential confounding of study results, interference with patient compliance with the study protocol throughout the study treatment period, or not in the best interest of the patient. 17. The patient received a platelet or red blood cell transfusion within 3 days before the start of treatment with the study drug. 18. Pregnant or lactating patients, or those planning to become pregnant during the study treatment period. 19. Clinically unresolved prior treatment toxicity (≥ grade 2), excluding alopecia, neuropathy, lymphocytopenia, and skin hypopigmentation. 20. Persons involved in the planning or implementation of the study.

Treatments Being Tested

DRUG

Fluzoparib

Fluzoparib (50mg per capsule) 150mg po bid, with a treatment cycle of 28 days. Administer 2 cycles in total.

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 (NCT06541314), 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 NCT06541314 clinical trial studying?

This study is an interventional, single-arm, open-label clinical trial. To evaluate the safety and efficacy of Fluzoparib as neoadjuvant therapy in patients with FIGO stage III and IV , BRCA mutations or HRD positive epithelial ovarian cancer who cannot achieve R0 surgery as assessed by imaging (Suidan's CT score) or laparoscopy (Fagotti score), or cannot tolerate surgery. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06541314?

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 NCT06541314?

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 NCT06541314. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06541314. 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.