Combining Fluzoparib and Bevacizumab for Ovarian Cancer Treatment
A Prospective, Single-arm, Multicenter Phase Ⅱ Clinical Study of Fluzoparib Combined With Bevacizumab in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With PARPi
This study is testing if combining two drugs, fluzoparib and bevacizumab, can help women with recurrent ovarian cancer feel better and stay in remission longer after their previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Chongqing University Cancer Hospital Academic / other |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05551208 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of fluzoparib combined with bevacizumab in patients with platinum-sensitive recurrent ovarian cancer who have previously been treated with PARP inhibitors. The study aims to enroll 42 patients who have experienced a relapse after receiving platinum-based chemotherapy. Participants will receive maintenance therapy with fluzoparib and bevacizumab after achieving remission or partial remission. The trial will evaluate progression-free survival, overall response rate, disease control rate, duration of response, and safety, alongside genetic testing to identify potential biomarkers for treatment response.
Who should consider this trial
Good fit: Ideal candidates are ovarian cancer patients aged 18-75 with measurable lesions who have received platinum-based chemotherapy and experienced relapse more than 6 months after their last treatment.
Not a fit: Patients who have used bevacizumab within the last 6 months or have untreated central nervous system metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could improve outcomes for ovarian cancer patients who have developed resistance to previous therapies.
How similar studies have performed: Previous studies have shown promising results with similar combinations of PARP inhibitors and bevacizumab, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ovarian cancer patients with histopathological type: low/high grade serous carcinoma, endometrioid carcinoma,had received platinum-based regimens for at least 1-3 lines after primary cytoreductive surgery. 2. The patient had at least one measurable lesion according to the RECIST V1.1 criteria. 3. The time from the last cycle of chemotherapy to relapse/progression should be more than 6 months. 4. ECOG score 0\~1,age 18\~75 years old 5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial 6. CBC Hb≥90g/L, ANC≥1.5×109/L, PLT≥100×109/L, 7. Serum ALT≤3×UL, AST≤3×ULN#Serum creatinine≤1.5×ULN# Exclusion Criteria: 1. Had used bevacizumab within 6 months of enrollment 2. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated. The patients had untreated CNS metastases. 3. The patient had Recent intestinal obstruction, gastrointestinal perforation within 3 months, uncontrolled high blood pressure after medication (Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg), Moderate to severe cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), moderate to severe deep vein thrombosis and moderate to severe pulmonary embolism occurred within 6 months before enrollment. Patient with coagulation dysfunction. 4. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 5. Activity or uncontrol severe infection
Where this trial is running
Chongqing, Chongqing Municipality
- Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zou Dongling, M.D. — Chongqing University Cancer Hospital
- Study coordinator: Zou Dongling, PH.D.
- Email: cqzl_zdl@163.com
- Phone: +8613657690699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.