Clinical trial · Interventional
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer
NCT05819060CI-TRIAL-00065804unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fuzuloparib Combination with Bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fuzuloparib Combination with Bevacizumab
- description
- Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg,d1,Q3W
- interventionNames
- Drug: Fuzuloparib Combination with Bevacizumab
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- approximately 1.5 years
- description
- according to RECIST v1.1
Secondary outcomes (2)
- measure
- Overall survival (OS)
- timeFrame
- Up to approximately 1.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.