ClinicalTrials.gg
Not yet recruitingNCT07647653Updated Jun 15, 2026

Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanced Ovarian Cancer

A Phase 2 interventional study of Olaparib+Bevacizumab and Fluzoparib+Bevacizumab in Ovarian Cancer, sponsored by Shandong University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Shandong University · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 22 studies testing fluzoparib in Ovarian Neoplasms — 13 open to participants now, 13 under way, 1 of them phase 3. fluzoparib · Ovarian Neoplasms.

Planned enrollment
5th of 22
120 · median 70
Started
2026
with 1 other
Phase 2
15 of 22
12 open now
Primary completion
2031-02
later than 12 of 12 live
Registered
22nd of 22
by date
Lead sponsor
1 of 22
Shandong University

Among the 22 studies testing fluzoparib in Ovarian Neoplasms, this one is the 5th largest by planned enrollment, is one of 2 that started in 2026, is one of 15 in phase 2, reaches primary completion later than 12 of the 12 other live ones, and was the 22nd registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

13 of the 22 studies testing fluzoparib in Ovarian Neoplasms are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Where they have run

About fluzoparib

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies testing fluzoparib in Ovarian Neoplasms, or all of them as a file.
02

Study summary

The PAOLA-1 trial demonstrated that for HRD-positive patients who received first-line chemotherapy combined with bevacizumab, sequential maintenance therapy with olaparib plus bevacizumab yielded a progression-free survival (PFS) of up to 46.8 months, with an olaparib-related treatment discontinuation rate of approximately 20%.

The combination of olaparib and bevacizumab has been recommended by multiple clinical guidelines as the first-line maintenance regimen for HRD-positive patients treated with first-line chemotherapy plus bevacizumab. This regimen has obtained approved indications and been covered by national medical insurance. In clinical practice, around 30% of patients receiving chemotherapy plus bevacizumab adopt olaparib combined with bevacizumab for first-line maintenance treatment.

Fluzoparib has been approved in China for first-line maintenance therapy in the overall patient population. The treatment discontinuation rate of fluzoparib plus apatinib is merely about 2%. However, there is currently no available data regarding fluzoparib combined with bevacizumab in the HRD-positive population, and the clinical value of this regimen remains to be further explored.

This study aims to generate efficacy and safety data for olaparib plus bevacizumab versus fluzoparib plus bevacizumab in HRD-positive patients who have undergone first-line chemotherapy combined with bevacizumab, so as to provide objective evidence for clinical medication decisions.

03

Conditions studied

  • Ovarian Cancer

Browse trials for

Keywords

  • Ovarian Cancer
  • first-line maintenance
  • PARPi
  • bevacizumab
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The participant voluntarily agrees to take part in the study, signs the form, demonstrates good treatment compliance, and is willing to complete scheduled follow-up.
  2. Female participants aged ≥ 18 years (age calculated on the date of signing the informed consent form).
  3. Newly diagnosed high-grade (or moderately/poorly differentiated) serous ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma; or grade II and higher ovarian endometrioid adenocarcinoma.

    For mixed tumors: The proportion of high-grade serous component or grade II+ endometrioid component must exceed 50%.

  4. Disease staged as Stage III or Stage IV per the 2018 FIGO staging system.
  5. Confirmed HRD (Homologous Recombination Deficiency)-positive status via laboratory testing.
  6. The participant has received 6 to 9 cycles of platinum-based chemotherapy. For participants who cannot tolerate chemotherapy for documented reasons, a minimum of 4 cycles of platinum-based chemotherapy is required.Prior to randomization, participants must have received bevacizumab combined with platinum-based chemotherapy for at least the final 3 cycles, with a minimum of 3 cycles of bevacizumab administration.For participants undergoing interval debulking surgery (IDS), a minimum of 2 cycles of bevacizumab combined with the final 3 cycles of platinum-based chemotherapy is acceptable.
  7. Prior to randomization, participants must have No Evidence of Disease (NED), or be assessed as having achieved Complete Response (CR) or Partial Response (PR) after platinum-based chemotherapy, and maintain this status until initiation of study treatment. Randomization and study drug administration must be completed within 8 weeks after the last dose of chemotherapy.
  8. Performance Status (ECOG-PS) score: 0 or 1.
  9. Major organ function meets the following requirements. Use of any blood products or hematopoietic growth factors is prohibited within 14 days prior to randomization:

(ANC) ≥ 1.5 × 10⁹/L count ≥ 90 × 10⁹/L ≥ 9 g/dL Serum albumin ≥ 3 g/dL Total ≤ 1.5 × (ALT) and Aspartate Transaminase (AST) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN 10、For women of : A negative serum pregnancy test result must be obtained within 72 hours prior to randomization. Participants must agree to use one medically approved method throughout the study treatment period and for 6 months after the last dose of study drug. Participants must not be breastfeeding.

Exclusion criteria

Exclusion Criteria:

  1. History of other untreated malignant tumors within the past 5 years, or concurrent untreated malignant tumors.

    Exceptions: cured thyroid carcinoma, cutaneous basal cell carcinoma, cervical carcinoma in situ, and breast cancer with no recurrence for more than 3 years after radical resection.

  2. Presence of untreated central nervous system (CNS) . Exception: Participants who have received definitive systemic or radical treatment (radiotherapy or surgery) for brain or meningeal metastases, with radiologically confirmed stable disease for at least 1 month, who have discontinued systemic therapy (prednisone > 10 mg/day or equivalent glucocorticoids) for more than 2 weeks and have no associated clinical symptoms are eligible.
  3. Prior exposure to any PARP inhibitors, including but not limited to olaparib, niraparib, rucaparib, pamiparib and fluzoparib.
  4. Inability to swallow oral tablets normally, or presence of gastrointestinal dysfunction that may interfere with drug absorption, as judged by the investigator.
  5. History of intestinal obstruction or gastrointestinal perforation within the past 3 months.
  6. Symptomatic malignant ascites or pleural effusion requiring paracentesis or drainage; or history of ascites/pleural effusion drainage within 3 months prior to randomization.
  7. Uncontrolled cardiac symptoms or diseases, including:

(1) Heart failure with Functional Class ≥ 2; (2) Unstable angina pectoris; (3) Myocardial infarction within the past 1 year; (4) supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) > 470 ms. 8、Coagulopathy defined as (INR) > 1.5 or Prothrombin Time (PT) > + 4 seconds; presence of bleeding diathesis, or receipt of thrombolytic or systemic anticoagulant therapy.

Exception: Prophylactic anticoagulation with low-dose low-molecular-weight heparin or oral aspirin is allowed during the study.

9、Clinically significant bleeding events or definite bleeding diathesis within 3 months prior to randomization (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, vasculitis).

10、If the baseline fecal occult blood test is positive, repeat testing is permitted. If the repeat test remains positive, clinical evaluation is required, and gastroscopy shall be performed if necessary.

11、Presence of active ulcers, unhealed wounds or fractures. Uncontrolled hypertension despite standard antihypertensive therapy (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).

12、Any bleeding event graded ≥ Grade 2 per v6.0 within 4 weeks prior to randomization.

13、Active infection, or unexplained fever > 38.5 °C during the screening period or prior to randomization.

14、Congenital or acquired immunodeficiency (e.g., infection), or active viral hepatitis.

15、Prior radiotherapy, chemotherapy, hormonal therapy or molecular targeted therapy completed less than 4 weeks before study drug administration (less than 5 drug half-lives for oral molecular targeted agents). Adverse events from previous anti-tumor therapies have not recovered to Grade ≤ 1 per CTCAE v6.0 (alopecia is excluded).

16、History of arterial or venous thromboembolic events within 6 months prior to randomization, including cerebrovascular accident (, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.

17、Hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, thrombocytopenia).

18、Plan to receive other systemic anti-tumor therapy during the study period. 19、Any other medical conditions or circumstances that may lead to premature termination of the study, as judged by the investigator.

Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    fluzoparib + bevacizumab

    Fluzoparib Capsules: Administered orally at a dose of 3 capsules (150 mg) twice daily for a total duration of 2 consecutive years. Morning and evening dosing is allowed, and the drug may be taken with or without food; it is recommended to take each dose within 0.5 hours after breakfast and dinner, with continuous administration throughout the treatment period. Bevacizumab Injection is administered via intravenous infusion at a dose of 15 mg/kg once every 3 weeks. The treatment cycle is repeated every 3 weeks, and administration is continued until disease progression or intolerable toxicity develops, with a maximum total treatment duration of 15 months.

    Drug: Fluzoparib+Bevacizumab

  • Experimental
    olaparib plus bevacizumab

    Administered orally at a dose of 2 tablets (300 mg) twice daily for a total duration of 2 consecutive years. It is recommended to take the drug at fixed times in the morning and evening on an empty stomach (either 1 hour before a meal or 2 hours after a meal), with continuous administration throughout the treatment period. Bevacizumab Injection is administered via intravenous infusion at a dose of 15 mg/kg once every 3 weeks. The treatment cycle is repeated every 3 weeks, and administration is continued until disease progression or intolerable toxicity develops, with a maximum total treatment duration of 15 months.

    Drug: Olaparib+Bevacizumab

Interventions

  • DrugOlaparib+Bevacizumab

    Drug pages: Olaparib · Bevacizumab

    Olaparib Tablets: Administered orally at a dose of 2 tablets (300 mg) twice daily for a total duration of 2 consecutive years. It is recommended to take the drug at fixed times in the morning and evening on an empty stomach (either 1 hour before a meal or 2 hours after a meal), with continuous administration throughout the treatment period. Bevacizumab Injection is administered via intravenous infusion at a dose of 15 mg/kg once every 3 weeks. The treatment cycle is repeated every 3 weeks, and administration is continued until disease progression or intolerable toxicity develops, with a maximum total treatment duration of 15 months.

  • DrugFluzoparib+Bevacizumab

    Drug pages: Fluzoparib · Bevacizumab

    Fluzoparib Capsules: Administered orally at a dose of 3 capsules (150 mg) twice daily for a total duration of 2 consecutive years. Morning and evening dosing is allowed, and the drug may be taken with or without food; it is recommended to take each dose within 0.5 hours after breakfast and dinner, with continuous administration throughout the treatment period. Bevacizumab Injection is administered via intravenous infusion at a dose of 15 mg/kg once every 3 weeks. The treatment cycle is repeated every 3 weeks, and administration is continued until disease progression or intolerable toxicity develops, with a maximum total treatment duration of 15 months.

06

What researchers measure

Primary outcomes

  1. 12-month Progression-Free Survival (PFS) Rate

    The proportion of participants who remain free of disease progression (as per RECIST v1.1) or death from any cause at 12 months after randomization.

    Time frame: From date of randomization up to 12 months post-randomization for rate assessment; overall study assessment is conducted up to 96 months.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    The time from randomization to the occurrence of disease progression (as per RECIST v1.1) or death from any cause, whichever occurs first.

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months

  2. Overall Survival (OS)

    The time from randomization to death due to any cause.

    Time frame: From date of randomization until the date of death from any cause, assessed up to 96 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Feb 2031, 55 months later.

Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 55 months is close to that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 15, 2026
StartEst.
Jun 30, 2026
Primary completionEst.
Feb 28, 2031
CompletionEst.
Feb 28, 2031
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07647653
Responsible party
Beihua Kong (Director, Department of Obstetrics and Gynecology, Shandong University) — Principal investigator
First posted
Jun 15, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Feb 28, 2031 (estimated)
Completion
Feb 28, 2031 (estimated)
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fluzoparib · Bevacizumab

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