Actively Recruiting
Fluzoparib Neoadjuvant Therapy for Ovarian Cancer
Led by Qilu Hospital of Shandong University · Updated on 2024-11-27
48
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fluzoparib Neoadjuvant Therapy for Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Biopsy-confirmed high-grade serous or endometrioid ovarian, peritoneal, or fallopian tube cancer at FIGO stage III-IV
- Presence of BRCA1/2 mutation or HRD positivity confirmed by designated testing
- Signed informed consent before trial procedures begin
- At least one measurable lesion assessable by CT or MRI
- Agree to provide blood and tissue samples before, during, and after treatment for research
- Deemed unable to achieve R0 cytoreduction or unable to tolerate surgery by gynecologic oncologists based on laparoscopic or CT scoring
- Expected survival longer than 12 weeks
- ECOG performance status score between 0 and 2
- Adequate bone marrow, liver, and kidney function as defined by specific laboratory values
- Negative pregnancy test for women of reproductive age and commitment to effective contraception during the study
- Understand and agree to comply with the trial protocol and procedures
- Willing to complete quality of life questionnaires during treatment and follow-up
- Any previous chemotherapy-related toxicities resolved to grade 1 or baseline except stable grade 2 or lower neuropathy or alopecia
You will not qualify if you...
- Participation in other investigational drug trials or use of other neoadjuvant cancer treatments during this study
- Known allergy to Fluzoparib or related compounds
- Inability to swallow oral medications or gastrointestinal disorders affecting drug absorption
- Previous treatment for ovarian cancer or prior PARP inhibitor therapy
- Symptomatic or uncontrollable brain metastases or spinal cord compression
- History of severe venous thrombosis or pulmonary embolism
- Recent major surgery within 3 weeks or not recovered from surgery
- Uncorrected electrolyte imbalances at dosing
- Other malignant diseases within the past 3 years except certain treated cancers
- History or current diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- Severe uncontrolled diseases or conditions judged unsuitable by investigators
- Recent platelet or red blood cell transfusion within 3 days before treatment
- Pregnant, breastfeeding, or planning pregnancy during treatment
- Unresolved prior treatment toxicity grade 2 or higher except specified conditions
- Individuals involved in planning or conducting the study
AI-Screening
AI-Powered 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, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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