AzTrials
AzTrials

Ovarian CancerPhase 2NCT06541314

Fluzoparib Neoadjuvant Therapy for Ovarian Cancer

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Fluzoparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
18 Jun 2024to 31 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18-75 years.
  • 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.
  • Presence of BRCA1/2 mutation or HRD positivity confirmed in tissue or blood samples by the designated testing institution of the study center.
  • 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.
  • The patient must have at least one measurable lesion that can be assessed by CT or MRI (RECIST 1.1).
  • 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.
Show all 14Show fewer
  • 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.
  • Expected survival time > 12 weeks.
  • Patients with an ECOG score of 0-2.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Concurrent use of other investigational drugs or participation in other clinical drug trials during this study.
  • 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.
  • Known allergy to Fluzoparib or any active or inactive components with a similar chemical structure to Fluzoparib.
  • 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.
  • Received any cancer-related treatment for ovarian cancer.
  • Previously received known or potential PARP inhibitor therapy.
Show all 20Show fewer
  • 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.
  • History of severe venous thrombosis or pulmonary embolism.
  • Received other molecular targeted therapy within 4 weeks before enrollment.
  • 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.
  • Undergone major surgery within 3 weeks before the start of the study, or not yet recovered from surgery.
  • Presence of uncorrected electrolyte disturbances at the time of dosing.
  • 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.
  • Patients have a history of or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • 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.
  • 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.
  • The patient received a platelet or red blood cell transfusion within 3 days before the start of treatment with the study drug.
  • Pregnant or lactating patients, or those planning to become pregnant during the study treatment period.
  • Clinically unresolved prior treatment toxicity (≥ grade 2), excluding alopecia, neuropathy, lymphocytopenia, and skin hypopigmentation.
  • Persons involved in the planning or implementation of the study.

Trial locations and contacts

1 site in 1 country.

Hualei Bu, PhD contact

(+86)053182165881

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

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.

Conditions
Ovarian Cancer
Being tested
Fluzoparib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • FluzoparibDrug

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

Study groups in NCT06541314
Study groupRoleWhat they receive
Fluzoparib neoadjuvant therapyExperimentalNot described
Receives: Drug: Fluzoparib

What is being measured

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

  1. ORR

    Objective response rate. After completing neoadjuvant monotherapy with Fluzoparib, the proportion of patients who achieve complete response and partial response according to the RECIST 1.1 criteria.

    Measured: From the diagnosis of epithelial ovarian cancer until the completion of neoadjuvant monotherapy with Fluzoparib, assessed up to 10 weeks.

  2. R0 Resection Rate

    To evaluate the proportion of patients with advanced epithelial ovarian cancer, initially deemed non-R0 resectable or unable to tolerate surgery, who achieve R0 resection following neoadjuvant monotherapy with Fluzoparib.

    Measured: From the completion neoadjuvant monotherapy with Fluzoparib until the date of surgery, with the assessment of R0 resection rate occurring within 1 to 2 weeks after treatment completion.

Secondary outcomes (2)

  1. PFS

    Progression-free survival. 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.

  2. OS

    Overall survival. The time from patient enrollment to death.

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

Timeline

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

  1. First posted7 Aug 2024
  2. Study start18 Jun 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06541314
Sponsor's protocol ID
KYLL-202404-015-1
Status last verified
May 2024
First submitted
13 Jun 2024
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
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 in people with Ovarian 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 14 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 27 Nov 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hualei Bu, PhD ((+86)053182165881, 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?

ORR (time frame: From the diagnosis of epithelial ovarian cancer until the completion of neoadjuvant monotherapy with Fluzoparib, assessed up to 10 weeks.). The study lists 2 primary outcomes in all. 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 NCT06541314.

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 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in