Actively Recruiting
Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
Led by Qilu Hospital of Shandong University · Updated on 2024-12-16
105
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent
- Aged 18 years or older
- Newly diagnosed with FIGO stage III-IV high-grade or moderate/low-grade serous ovarian, fallopian tube, or primary peritoneal cancer; or grade II or higher endometrioid adenocarcinoma of the ovary
- Has at least one measurable tumor lesion assessable by CT or MRI
- Unable to achieve complete tumor removal by surgery or cannot tolerate surgery as determined by investigator
- Expected survival longer than 12 weeks
- ECOG performance status between 0 and 2
- Confirmed germline BRCA1/2 mutation by genetic testing
- Adequate major organ function meeting specified blood count and biochemical criteria
- Female patients of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during and for 6 months after treatment
- Willing to complete quality of life surveys during treatment and follow-up
You will not qualify if you...
- Other untreated malignant tumors within 5 years except certain cured cancers
- Untreated central nervous system metastases unless stable and treated as specified
- Previous treatment with PARP inhibitors or Bevacizumab
- Unable to swallow tablets or with gastrointestinal dysfunction affecting drug absorption
- Recent bowel obstruction or gastrointestinal perforation within 3 months
- Poorly controlled heart disease or significant cardiac conditions
- Recent significant bleeding or bleeding disorders
- Recent blood transfusions within 14 days before treatment
- Active ulcers, non-healing wounds, or fractures
- Severe bleeding events within 4 weeks before treatment
- Active infections or unexplained fever above 38.5°C
- Immune deficiency or active hepatitis infections
- Recent other cancer treatments or unresolved treatment side effects
- Recent arterial thrombosis or severe venous thromboembolic events within 6 months
- History of bleeding or coagulation disorders
- Receiving other systemic antitumor treatments during the study
- Uncontrolled high blood pressure despite treatment
- Pregnant or breastfeeding, or planning pregnancy during the study
- Other severe diseases, psychiatric disorders, or social/family factors impacting safety or data collection as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
H
Hualei Bu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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