The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab

• Status: Not yet recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: Female

Summary

The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

1. Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;

2. Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;

3. Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;

4. Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;

5. The patient achieved a complete or partial response after the last platinum-based chemotherapy;

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

7. The patient has a life expectancy of at least 3 months and sufficient organ function;

8. The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;

9. The patient voluntarily agrees to participate in this study and signs an informed consent form.

Exclusion Criteria:

1. Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;

2. Patients who have undergone major surgery within 28 days prior to enrollment;

3. Patients with central nervous system metastases or a history of seizures within the past 12 months;

4. Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;

5. NYHA functional class ≥ III;

6. Patients with severe, uncontrolled systemic diseases;

7. Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;

8. Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;

9. Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;

10. Patients judged by the investigator to be unsuitable for participation in this study.