Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The subject voluntarily agrees to participate and signs the informed consent form.
Age ≥18 years (calculated as of the date of signing the informed consent).
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%.
The subject has at least one measurable lesion that can be assessed by CT or MRI (RECIST v1.1).
Disqualifiers
Patients with other untreated malignant tumors within the past 5 years, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and breast cancer without relapse for over 3 years after radical surgery.
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.
Patients who have previously received treatment with known or potential PARP inhibitors or Bevacizumab.
Patients unable to swallow tablets or with gastrointestinal dysfunction that may affect drug absorption, as judged by the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
Fluzoparib
DrugFluzoparib capsule (50mg per capsule) 150mg po BID
Bevacizumab
DrugBevacizumab injection (100mg per vial) 7.5mg/kg ivdrip Q3W
Paclitaxel
DrugPaclitaxel injection 135-175mg/㎡ ivdrip Q3W
Carboplatin
DrugCarboplatin injection AUC=4-5 ivdrip Q3W
Treatment groups
105 Participants
are divided into 3 treatment groupsGroup A: Fluzoparib monotherapyExperimental treatment 1 intervention
Group B: Fluzoparib in combination with BevacizumabExperimental treatment 2 interventions
Group C: Paclitaxel plus CarboplatinActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
The percentage of patients who achieve a complete response (CR) or partial response (PR) as determined by the investigator based on RECIST v1.1 criteria, at the end of neoadjuvant treatment.
Time frame
At the end of neoadjuvant treatment. The Fluzoparib monotherapy and Fluzoparib plus Bevacizumab groups will receive 2 cycles of treatment (28 days per cycle). The Paclitaxel plus Carboplatin group will receive 3 cycles of treatment (21 days per cycle).Secondary outcomes
1
R0 resection rate
To evaluate the proportion of patients who achieve R0 resection following neoadjuvant therapy.
Time frame
Immediately after final interval debulking surgery.2
pCR
Pathological complete response.
Time frame
Post-surgical pathology (up to 2 weeks post surgery).3
Overall survival (OS)
The time from patient enrollment to death.
Time frame
The time from patient enrollment until the date of death from any cause, assessed up to 120 months.4
Progression free survival (PFS)
The time from patient enrollment to tumor progression or death.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov