Ovarian CancerPhase 2NCT07033819
Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib
A Phase 2 study testing Neoadjuvant therapy with fuzuloparib in combination with apatinib, Preoperative Period and Chemotherapy in people with Ovarian Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Neoadjuvant therapy with fuzuloparib in combination with apatinib, Preoperative Period and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Bin Li Chief Physician, +86-13801364117, lb87960440@vip.sina.com
About this study
Official title: 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
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.
Read the detailed description
This study is a single-arm, interventional, open-label, prospective clinical trial. Patients with advanced epithelial ovarian cancer (Federation of International of Gynecologists and Obstetricians，FIGO stage III-IV), who are not eligible for R0 resection or unable to tolerate surgery based on radiological assessment (Suidan score) or laparoscopic assessment (Fagotti score), and who are Homologous recombination deficiency （HRD）positive, will receive neoadjuvant therapy with fuzuloparib and apatinib for two cycles (28 days per cycle). After neoadjuvant treatment, patients who achieve complete or partial response according to radiological assessment will proceed to the surgical treatment phase.
- Conditions
- Ovarian Cancer
- Being tested
- Neoadjuvant therapy with fuzuloparib in combination with apatinib, Preoperative Period, Chemotherapy, Maintenance treatment
- Keywords
- ovarian cancer, neoadjuvant therapy, targeted therapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant therapy with fuzuloparib in combination with apatinibDrug
Also called Neoadjuvant therapy
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.
Preoperative PeriodProcedure or surgery
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.
ChemotherapyDrug
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).
Maintenance treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant therapy | Experimental | Participants will receive neoadjuvant therapy with fuzuloparib and apatinib for a total of two cycles (28 days per cycle). Receives: Drug: Neoadjuvant therapy with fuzuloparib in combination with apatinib; Procedure: Preoperative Period; Drug: Chemotherapy; Drug: Maintenance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection Rate
Proportion of patients with advanced epithelial ovarian cancer who are not R0 resectable at first diagnosis or who cannot tolerate surgery who undergo tumour cytoreduction to achieve R0 resection.
Measured: 4 months
Secondary outcomes (4)
Objective Remission Rate (ORR)
The proportion of patients whose tumor volume decreases by a predetermined amount and maintains this reduction for the minimum required duration. It is the sum of the complete response (CR) and partial response (PR) rates. In other words, ORR = CR + PR.
Measured: 24 months
Progression-Free Survival (PFS)
The time from randomization until tumor progression (as defined by RECIST 1.1 criteria) or death from any cause, whichever occurs first.
Measured: 24 months
Disease Control Rate (DCR)
The percentage of evaluable patients who achieve a response (PR + CR) or stable disease (SD) after treatment. Simply put, DCR = CR + PR + SD, according to the RECIST criteria for at least 4 weeks.
Measured: 24 months
Overall Survival (OS)
The time from randomization until death from any cause. For subjects who are lost to follow-up before death, the last follow-up time is usually counted as the time of death.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 Jun 2025
- Primary completion20 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033819
- Sponsor's protocol ID
- 24/463-4743
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07033819
- Acronym / sponsor ID
- 24/463-4743
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, neoadjuvant therapy, targeted therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a single-arm, interventional, open-label, prospective clinical trial. Patients with advanced epithelial ovarian cancer (Federation of International of Gynecologists and Obstetricians，FIGO stage III-IV), who are not eligible for R0 resection or unable to tolerate surgery based on radiological assessment (Suidan score) or laparoscopic assessment (Fagotti score), and who are Homologous recombination deficiency （HRD）positive, will receive neoadjuvant therapy with fuzuloparib and apatinib for two cycles (28 days per cycle). After neoadjuvant treatment, patients who achieve complete or partial response according to radiological assessment will proceed to the surgical treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant therapy | Experimental | Drug: Neoadjuvant therapy with fuzuloparib in combination with apatinib, Procedure: Preoperative Period, Drug: Chemotherapy, Drug: Maintenance treatmentParticipants will receive neoadjuvant therapy with fuzuloparib and apatinib for a total of two cycles (28 days per cycle). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant therapy with fuzuloparib in combination with apatinibAlso: Neoadjuvant therapyNeoadjuvant 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. | Drug | neoadjuvant therapy |
| Preoperative PeriodDiscontinue 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. | Procedure or surgery | neoadjuvant therapy |
| ChemotherapyPostoperative 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 | neoadjuvant therapy |
| Maintenance treatmentMaintenance 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. | Drug | neoadjuvant therapy |
Primary outcome
R0 Resection Rate
Time frame: 4 months
Proportion of patients with advanced epithelial ovarian cancer who are not R0 resectable at first diagnosis or who cannot tolerate surgery who undergo tumour cytoreduction to achieve R0 resection.
4 secondary outcomes
Objective Remission Rate (ORR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant therapy with fuzuloparib in combination with apatinib, Preoperative Period and Chemotherapy in people with Ovarian Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Li Bin Li, PhD (86+13801364117, libin@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 Resection Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.