Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanc… (NCT07647653) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanced Ovarian Cancer
120 participantsStarted 2026-06-30
Plain-language summary
The PAOLA-1 trial demonstrated that for HRD-positive patients who received first-line chemotherapy combined with bevacizumab, sequential maintenance therapy with olaparib plus bevacizumab yielded a progression-free survival (PFS) of up to 46.8 months, with an olaparib-related treatment discontinuation rate of approximately 20%.
The combination of olaparib and bevacizumab has been recommended by multiple clinical guidelines as the first-line maintenance regimen for HRD-positive patients treated with first-line chemotherapy plus bevacizumab. This regimen has obtained approved indications and been covered by national medical insurance. In clinical practice, around 30% of patients receiving chemotherapy plus bevacizumab adopt olaparib combined with bevacizumab for first-line maintenance treatment.
Fluzoparib has been approved in China for first-line maintenance therapy in the overall patient population. The treatment discontinuation rate of fluzoparib plus apatinib is merely about 2%. However, there is currently no available data regarding fluzoparib combined with bevacizumab in the HRD-positive population, and the clinical value of this regimen remains to be further explored.
This study aims to generate efficacy and safety data for olaparib plus bevacizumab versus fluzoparib plus bevacizumab in HRD-positive patients who have undergone first-line chemotherapy combined with bevacizumab, so as to provide objective evidence for clinical medication decisions.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant voluntarily agrees to take part in the study, signs the informed consent form, demonstrates good treatment compliance, and is willing to complete scheduled follow-up.
. Female participants aged ≥ 18 years (age calculated on the date of signing the informed consent form).
. Newly pathologically diagnosed high-grade (or moderately/poorly differentiated) serous ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma; or grade II and higher ovarian endometrioid adenocarcinoma.
. Disease staged as Stage III or Stage IV per the 2018 FIGO staging system.
. Confirmed HRD (Homologous Recombination Deficiency)-positive status via laboratory testing.
. The participant has received 6 to 9 cycles of platinum-based chemotherapy. For participants who cannot tolerate chemotherapy for documented reasons, a minimum of 4 cycles of platinum-based chemotherapy is required.Prior to randomization, participants must have received bevacizumab combined with platinum-based chemotherapy for at least the final 3 cycles, with a minimum of 3 cycles of bevacizumab administration.For participants undergoing interval debulking surgery (IDS), a minimum of 2 cycles of bevacizumab combined with the final 3 cycles of platinum-based chemotherapy is acceptable.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
12-month Progression-Free Survival (PFS) Rate
Timeframe: From date of randomization up to 12 months post-randomization for rate assessment; overall study assessment is conducted up to 96 months.
. Prior to randomization, participants must have No Evidence of Disease (NED), or be assessed as having achieved Complete Response (CR) or Partial Response (PR) after first-line platinum-based chemotherapy, and maintain this status until initiation of study treatment. Randomization and study drug administration must be completed within 8 weeks after the last dose of chemotherapy.
. ECOG Performance Status (ECOG-PS) score: 0 or 1.
Exclusion criteria
. History of other untreated malignant tumors within the past 5 years, or concurrent untreated malignant tumors.
. Presence of untreated central nervous system (CNS) metastases. Exception: Participants who have received definitive systemic or radical treatment (radiotherapy or surgery) for brain or meningeal metastases, with radiologically confirmed stable disease for at least 1 month, who have discontinued systemic glucocorticoid therapy (prednisone \> 10 mg/day or equivalent glucocorticoids) for more than 2 weeks and have no associated clinical symptoms are eligible.
. Prior exposure to any PARP inhibitors, including but not limited to olaparib, niraparib, rucaparib, pamiparib and fluzoparib.
. Inability to swallow oral tablets normally, or presence of gastrointestinal dysfunction that may interfere with drug absorption, as judged by the investigator.
. History of intestinal obstruction or gastrointestinal perforation within the past 3 months.
. Symptomatic malignant ascites or pleural effusion requiring paracentesis or drainage; or history of ascites/pleural effusion drainage within 3 months prior to randomization.
. Uncontrolled cardiac symptoms or diseases, including: