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Ovarian CancerPhase 2NCT06735326

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

A Phase 2 study testing Fluzoparib, Bevacizumab and Paclitaxel in people with Ovarian Cancer and Fallopian Tube Cancer, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Fluzoparib, Bevacizumab and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteChina
Study dates
27 Nov 2024to 1 Oct 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject voluntarily agrees to participate and signs the informed consent form.
  • Age ≥18 years (calculated as of the date of signing the informed consent).
  • 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%.
  • The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1).
  • According to the investigator's assessment, the patient is unable to achieve R0 resection or cannot tolerate surgery.
  • 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.
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  • 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.
  • Expected survival >12 weeks.
  • ECOG performance status: 0-2.
  • Confirmed germline BRCA1/2 mutations by professional genetic testing.
  • Function of major organs meets the following requirements (no blood products or colony-stimulating factors allowed within 14 days prior to the first dose):
  • Absolute neutrophil count ≥1.5 × 10^9/L.
  • Platelet count ≥100 × 10^9/L.
  • Hemoglobin ≥9 g/dL.
  • Serum albumin ≥3 g/dL.
  • Bilirubin ≤1.5 times the upper limit of normal (ULN).
  • ALT and AST ≤2.5 times ULN, must be ≤5 times ULN in the presence of liver metastases.
  • Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula).
  • 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.
  • 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.

Who cannot join

  • 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.
  • 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.
  • Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab.
  • Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator.
  • Patients who have experienced bowel obstruction or gastrointestinal perforation within the last 3 months.
  • Patients with poorly controlled heart conditions or diseases, such as:
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  • NYHA Class II or higher heart failure.
  • Unstable angina.
  • Myocardial infarction within 1 year.
  • Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
  • QTc >470 ms.
  • 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.
  • Patients who have received platelet or red blood cell transfusion within 14 days before starting treatment.
  • Patients with active ulcers, non-healing wounds, or fractures.
  • Patients who have experienced any severe bleeding event graded ≥2 in CTCAE 5.0 within 4 weeks before the first dose.
  • Patients with active infections or unexplained fever >38.5°C during screening or before the first dose.
  • 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).
  • 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.
  • 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.
  • Patients with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, platelet dysfunction, thrombocytopenia, etc.).
  • Patients who may receive other systemic antitumor treatments during the study period.
  • Patients with uncontrolled hypertension, despite antihypertensive treatment (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
  • Pregnant or breastfeeding women, or women planning pregnancy during the study treatment.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hualei Bu contact

(+86)0531-82165881

buhualei@email.sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

    Hualei Bu, Dr., +8682165881

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Fluzoparib, Bevacizumab, Paclitaxel, Carboplatin
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluzoparibDrug

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

  • BevacizumabDrug

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

  • PaclitaxelDrug

    Paclitaxel injection 135-175mg/㎡ ivdrip Q3W

  • CarboplatinDrug

    Carboplatin injection AUC=4-5 ivdrip Q3W

Study groups in NCT06735326
Study groupRoleWhat they receive
Fluzoparib monotherapyExperimentalFluzoparib capsules with a treatment cycle of 28 days, for a total of 2 cycles.
Receives: Drug: Fluzoparib
Fluzoparib in combination with BevacizumabExperimentalFluzoparib capsules with a treatment cycle of 28 days, for a total of 2 cycles; in combination with Bevacizumab injection (7.5mg/kg, intravenous infusion, administered once every three weeks), for a total of 2 doses.
Receives: Drug: Fluzoparib; Drug: Bevacizumab
Paclitaxel plus CarboplatinActive comparatorPaclitaxel injection plus Carboplatin injection, administered once every three weeks for a total of 3 doses. If there is an allergy to Paclitaxel, it is recommended to replace it with Docetaxel or Liposomal Doxorubicin.
Receives: Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    The percentage of patients who achieve a complete response (CR) or partial response (PR) as determined by the investigator based on RECIST v1.1 criteria, at the end of neoadjuvant treatment.

    Measured: At the end of neoadjuvant treatment. The Fluzoparib monotherapy and Fluzoparib plus Bevacizumab groups will receive 2 cycles of treatment (28 days per cycle). The Paclitaxel plus Carboplatin group will receive 3 cycles of treatment (21 days per cycle).

Secondary outcomes (6)

  1. R0 resection rate

    To evaluate the proportion of patients who achieve R0 resection following neoadjuvant therapy.

    Measured: Immediately after final interval debulking surgery.

  2. pCR

    Pathological complete response.

    Measured: Post-surgical pathology (up to 2 weeks post surgery).

  3. Overall survival (OS)

    The time from patient enrollment to death.

    Measured: The time from patient enrollment until the date of death from any cause, assessed up to 120 months.

  4. Progression free survival (PFS)

    The time from patient enrollment to tumor progression or death.

    Measured: The time from patient enrollment until the date of first documented tumor progression or death from any cause, whichever occurs first, assessed up to 60 months.

  5. Safety evaluation

    Adverse events (AEs) during neoadjuvant treatment, surgery, chemotherapy, and maintenance therapy, grading based on NCI-CTCAE v5.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0). AEs are generally graded from 1 to 4, with higher grades indicating more worse conditions.

    Measured: From the start of neoadjuvant therapy to the end of maintenance therapy, assessed up to 30 months.

  6. Tolerability evaluation

    The proportion of dose interruptions, dose reductions, and dose discontinuations due to drug-related toxicities during the trial.

    Measured: From the start of neoadjuvant therapy to the end of maintenance therapy, assessed up to 30 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start27 Nov 2024
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06735326
Sponsor's protocol ID
KYLL-202410-008-1
Status last verified
Dec 2024
First submitted
25 Nov 2024
Last updated
16 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluzoparib, Bevacizumab and Paclitaxel in people with Ovarian Cancer and Fallopian Tube Cancer, run by Qilu Hospital of Shandong University 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 20 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 16 Dec 2024. 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 Hualei Bu ((+86)0531-82165881, buhualei@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: At the end of neoadjuvant treatment. The Fluzoparib monotherapy and Fluzoparib plus Bevacizumab groups will receive 2 cycles of treatment (28 days per cycle). The Paclitaxel plus Carboplatin group will receive 3 cycles of treatment (21 days per cycle).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06735326.

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 16 Dec 2024.

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