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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib

A Single-arm, Prospective Clinical Study of Fuzuloparib in Combination With Apatinib for Neoadjuvant Treatment of Homologous Recombination Deficiency Homologous Recombination Deficiency(HRD)-Positive Advanced Ovarian Cancer

Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib (NCT07033819) is a Phase 2 interventional studying Ovarian Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. 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

In this study, investigators propose to use fuzuloparib and apatinib as neoadjuvant therapy for Homologous recombination deficiency (HRD)positive advanced ovarian cancer patients, aiming to explore the efficacy and safety of this 'de-chemotherapy' regimen as neoadjuvant therapy for advanced ovarian cancer, and to conduct genetically related subgroup analyses, to guide the precision therapy and provide a new therapeutic option for HRD-positive patients with advanced ovarian cancer. To provide a new treatment option In order to increase the R0 resection rate of surgery and reduce chemotherapy resistance, thus improving the prognosis and prolonging the survival of patients.

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: - Newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with FIGO stage III-IV. - Age between 18 and 70 years. - Histopathological confirmation via laparoscopic biopsy or core needle biopsy indicating high-grade (or moderately/lowly differentiated) serous carcinoma, endometrioid carcinoma, fallopian tube cancer, or primary peritoneal cancer. - Eastern Cooperative oncology Group (ECOG) performance status of 0-1. - Positive for homologous recombination deficiency (HRD) based on tissue or blood sample testing. - Presence of at least one measurable lesion assessable by CT or MRI (RECIST v1.1). - Ineligibility for primary debulking surgery due to inability to achieve R0 resection or intolerance to surgery, based on: Fagotti laparoscopic score ≥8. Upper abdominal CT score ≥3 when laparoscopic assessment is not feasible. Judgment criteria for surgery intolerance: BMI ≥40.0. Multiple chronic diseases. Malnutrition or hypoalbuminemia. Moderate to large volume ascites. Newly diagnosed venous thromboembolism. ECOG performance status \>2. - Expected survival of \>3 months. - your organs (liver, kidneys, etc.) are working well enough based on blood tests, with laboratory results meeting the following criteria within 7 days prior to treatment initiation: Hematological tests (no transfusions or hematopoietic growth factor use within 7 days prior to screening): Hemoglobin (Hb) ≥90 g/L. Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Absolute lymphocyte count (LC) ≥0.5×10⁹/L. Platelet count (PLT) ≥100×10⁹/L. White blood cell count (WBC) ≥3.0×10⁹/L and ≤15×10⁹/L. Biochemical tests (no transfusions or albumin use within 7 days prior to screening): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Alkaline phosphatase (ALP) ≤2.5×ULN. Total bilirubin (TBIL) ≤1.5×ULN. ...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: * Newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with FIGO stage III-IV. * Age between 18 and 70 years. * Histopathological confirmation via laparoscopic biopsy or core needle biopsy indicating high-grade (or moderately/lowly differentiated) serous carcinoma, endometrioid carcinoma, fallopian tube cancer, or primary peritoneal cancer. * Eastern Cooperative oncology Group (ECOG) performance status of 0-1. * Positive for homologous recombination deficiency (HRD) based on tissue or blood sample testing. * Presence of at least one measurable lesion assessable by CT or MRI (RECIST v1.1). * Ineligibility for primary debulking surgery due to inability to achieve R0 resection or intolerance to surgery, based on: Fagotti laparoscopic score ≥8. Upper abdominal CT score ≥3 when laparoscopic assessment is not feasible. Judgment criteria for surgery intolerance: BMI ≥40.0. Multiple chronic diseases. Malnutrition or hypoalbuminemia. Moderate to large volume ascites. Newly diagnosed venous thromboembolism. ECOG performance status \>2. * Expected survival of \>3 months. * Adequate organ function, with laboratory results meeting the following criteria within 7 days prior to treatment initiation: Hematological tests (no transfusions or hematopoietic growth factor use within 7 days prior to screening): Hemoglobin (Hb) ≥90 g/L. Absolute neutrophil count (ANC) ≥1.5×10⁹/L. Absolute lymphocyte count (LC) ≥0.5×10⁹/L. Platelet count (PLT) ≥100×10⁹/L. White blood cell count (WBC) ≥3.0×10⁹/L and ≤15×10⁹/L. Biochemical tests (no transfusions or albumin use within 7 days prior to screening): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Alkaline phosphatase (ALP) ≤2.5×ULN. Total bilirubin (TBIL) ≤1.5×ULN. Serum creatinine (Cr) ≤1.5×ULN, with creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula). Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN, with international normalized ratio (INR) ≤1.5×ULN (not receiving anticoagulant therapy). Urinalysis: Urine protein \<2+; if urine protein ≥2+, then 24-hour urine protein quantification must show protein ≤1 g. 12-lead electrocardiogram (ECG): Fridericia-corrected QT interval (QTcF) \<470 ms for females. * Women of childbearing potential must have a negative serum or urine pregnancy test within one week prior to enrollment and must agree to use effective contraception during the study. * Any prior chemotherapy-related toxicities must have resolved to ≤CTCAE Grade 1 or baseline, except for stable sensory neuropathy or alopecia of ≤CTCAE Grade 2. * Voluntary participation in the study, with signed informed consent, good compliance, and willingness to participate in follow-up visits. Exclusion Criteria: * Hypersensitivity to the investigational drug or its excipients. * Concurrent use of other neoadjuvant therapies for tumors during the study, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbiological therapy, traditional Chinese medicine, or other experimental therapies. * Inability to swallow oral medications, or presence of gastrointestinal diseases that may interfere with the absorption or metabolism of the study drug, such as uncontrollable nausea and vomiting, gastrointestinal obstruction, or malabsorption. * Prior anti-cancer treatment for ovarian cancer. * Previous treatment with known or potential PARP inhibitors or anti-angiogenic agents. * Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids, or clinical manifestations of spinal cord compression. * History of severe venous thromboembolism or pulmonary embolism. * Receipt of other molecularly targeted therapies within 4 weeks prior to enrollment. * Major surgery within one month prior to the start of the study, or not yet recovered from surgery. * History of other malignancies within the past 3 years, except for adequately treated squamous cell carcinoma of the skin, basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ. * Prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). * Severe, uncontrolled medical conditions or investigator judgment that the participant is not suitable for the study, including but not limited to: active viral infections such as human immunodeficiency virus (HIV), hepatitis B, hepatitis C; severe cardiovascular disease, uncontrolled ventricular arrhythmias, myocardial infarction within the past 3 months; uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other psychiatric disorders affecting the ability to provide informed consent; uncontrolled hypertension; immunodeficiency (except splenectomy) or other diseases that the investigator deems may expose the patient to high-risk toxicity. * Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis B, hepatitis C (positive for HCV antibody and HCV-RNA above the lower limit of detection of the assay), or co-infection with hepatitis B and C. * Receipt of solid organ or hematopoietic stem cell transplantation during the study period (except for corneal transplantation). * Current participation in another interventional clinical study, or receipt of other investigational drugs or devices within 4 weeks prior to the first dose; not fully recovered from toxicities and/or complications of any prior interventions (i.e., ≤Grade 1 or returned to baseline, excluding fatigue or alopecia). * Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥110 mmHg despite optimal medical therapy). * Abnormal coagulation function (INR \>1.5 or prothrombin time (PT) \>ULN + 4 seconds or APTT \>1.5×ULN), history of bleeding tendency, or receiving thrombolytic or anticoagulant therapy. * Urinalysis showing proteinuria ≥++, or confirmed 24-hour urine protein ≥1.0 g. * History of substance abuse involving psychoactive drugs that cannot be discontinued, or participants with psychiatric disorders. * History of hereditary or acquired bleeding disorders or coagulopathies (specific inclusion to be determined by the investigator). * Concurrent use of strong CYP3A4 inhibitors (e.g., itraconazole, telithromycin, clarithromycin), moderate CYP3A4 inhibitors (e.g., ciprofloxacin, erythromycin, fluconazole), strong CYP3A4 inducers (e.g., phenobarbital, enzalutamide, phenytoin, rifampin), or moderate CYP3A4 inducers (e.g., bosentan, modafinil). A washout period of 5 weeks is required before study treatment for enzalutamide or phenobarbital, and 3 weeks for other drugs. * History of stroke or transient ischemic attack within the past 6 months. * Pregnant, breastfeeding, or planning to become pregnant during the study period (female participants). * Other severe medical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation, interfere with study treatment or outcomes, or any other situation deemed by the investigator as unsuitable for participation in the study.

Treatments Being Tested

DRUG

Neoadjuvant therapy with fuzuloparib in combination with apatinib

Neoadjuvant Treatment Period Fuzuloparib: 150 mg, twice daily, orally, either before or after meals. It is recommended to take it within 0.5 hours after breakfast and dinner. Continuous administration for 4 weeks constitutes one cycle, for a total of two cycles. Apatinib: 250 mg, once daily, orally, recommended to be taken within 0.5 hours after breakfast. Continuous administration for 4 weeks constitutes one cycle, for a total of two cycles.

PROCEDURE

Preoperative Period

Discontinue Fuzuloparib 7 days before surgery. Discontinue Apatinib 14 days before surgery. The specific timing will be assessed by the investigator based on postoperative wound healing.

DRUG

Chemotherapy

Postoperative Adjuvant Chemotherapy Period (≥4 cycles) Paclitaxel: 150-175 mg/m², intravenous infusion, every 3 weeks (Q3W). Carboplatin: AUC 4-5, intravenous infusion, every 3 weeks (Q3W).

DRUG

Maintenance treatment

Maintenance Treatment Period Fuzuloparib: 150 mg, twice daily, orally. Continuous administration for 4 weeks constitutes one cycle. Treatment will continue until disease progression, intolerable toxicity, or other reasons as specified in the protocol.

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.

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07033819), the sponsor (Cancer Institute and Hospital, Chinese Academy of Medical Sciences), 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 NCT07033819 clinical trial studying?

In this study, investigators propose to use fuzuloparib and apatinib as neoadjuvant therapy for Homologous recombination deficiency (HRD)positive advanced ovarian cancer patients, aiming to explore the efficacy and safety of this 'de-chemotherapy' regimen as neoadjuvant therapy for advanced ovarian cancer, and to conduct genetically related subgroup analyses, to guide the precision therapy and provide a new therapeutic option for HRD-positive patients with advanced ovarian cancer. To provide a new treatment option In order to increase the R0 resection rate of surgery and reduce chemotherapy re… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07033819?

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 NCT07033819?

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 NCT07033819. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07033819. 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 2026-06-26 · Data from ClinicalTrials.gov.