Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
NCT ID: NCT06735326
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
105 participants
INTERVENTIONAL
2024-11-27
2028-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fluzoparib monotherapy
Fluzoparib capsules with a treatment cycle of 28 days, for a total of 2 cycles.
Fluzoparib
Fluzoparib capsule (50mg per capsule) 150mg po BID
Fluzoparib in combination with Bevacizumab
Fluzoparib 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.
Fluzoparib
Fluzoparib capsule (50mg per capsule) 150mg po BID
Bevacizumab
Bevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W
Paclitaxel plus Carboplatin
Paclitaxel 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.
Paclitaxel
Paclitaxel injection 135-175mg/㎡ ivdrip Q3W
Carboplatin
Carboplatin injection AUC=4-5 ivdrip Q3W
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluzoparib
Fluzoparib capsule (50mg per capsule) 150mg po BID
Bevacizumab
Bevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W
Paclitaxel
Paclitaxel injection 135-175mg/㎡ ivdrip Q3W
Carboplatin
Carboplatin injection AUC=4-5 ivdrip Q3W
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥18 years (calculated as of the date of signing the informed consent).
3. 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%.
4. The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1).
5. According to the investigator's assessment, the patient is unable to achieve R0 resection or cannot tolerate surgery.
a) 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.
b) 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.
6. Expected survival \>12 weeks.
7. ECOG performance status: 0-2.
8. Confirmed germline BRCA1/2 mutations by professional genetic testing.
9. Function of major organs meets the following requirements (no blood products or colony-stimulating factors allowed within 14 days prior to the first dose):
1. Absolute neutrophil count ≥1.5 × 10\^9/L.
2. Platelet count ≥100 × 10\^9/L.
3. Hemoglobin ≥9 g/dL.
4. Serum albumin ≥3 g/dL.
5. Bilirubin ≤1.5 times the upper limit of normal (ULN).
6. ALT and AST ≤2.5 times ULN, must be ≤5 times ULN in the presence of liver metastases.
7. Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula).
10. 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.
11. 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.
Exclusion Criteria
2. 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.
3. Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab.
4. Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator.
5. Patients who have experienced bowel obstruction or gastrointestinal perforation within the last 3 months.
6. Patients with poorly controlled heart conditions or diseases, such as:
1. NYHA Class II or higher heart failure.
2. Unstable angina.
3. Myocardial infarction within 1 year.
4. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
5. QTc \>470 ms.
7. 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.
8. Patients who have received platelet or red blood cell transfusion within 14 days before starting treatment.
9. Patients with active ulcers, non-healing wounds, or fractures.
10. Patients who have experienced any severe bleeding event graded ≥2 in CTCAE 5.0 within 4 weeks before the first dose.
11. Patients with active infections or unexplained fever \>38.5°C during screening or before the first dose.
12. 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).
13. 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.
14. 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.
15. Patients with a history of hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, platelet dysfunction, thrombocytopenia, etc.).
16. Patients who may receive other systemic antitumor treatments during the study period.
17. Patients with uncontrolled hypertension, despite antihypertensive treatment (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
18. Pregnant or breastfeeding women, or women planning pregnancy during the study treatment.
19. 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Qilu Hospital of Shandong University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Beihua Kong
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Kun Song
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hualei Bu, Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KYLL-202410-008-1
Identifier Type: -
Identifier Source: org_study_id