A Study of Bevacizumab Combined With Fluzoparib/Chemotherapy or Fluzoparib in the Treatment of Ovarian Cancer

Study Overview
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Brief Summary
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This study was designed to explore the safety and efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.

Detailed Description
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This purpose of this study is to explore efficacy of Bevacizumab combined with Fluzoparib, Bevacizumab combined with chemotherapy or Fluzoparib monotherapy in patients with platinum-resistant recurrent ovarian cancer.Besides the efficacy,we focus on the safety and quality of life in the new treatments.

Official Title
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A Prospective Study of Bevacizumab Combined With Fluzoparib, Bevacizumab Combined With Chemotherapy or Fluzoparib Monotherapy in the Treatment of Platinum-resistant Recurrent Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: chemotherapy
* Drug: Fluzoparib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years, female; Recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer proven to be platinum-resistant by histology or cytology; ECOG score was 0-1; Expected survival time > 12 weeks; Normal or abnormal bone marrow, kidney, and liver function of the patient has no clinical significance, and the specific situation will be comprehensively determined by the investigator; Patients not previously treated with PARPi or targeted drugs; The patient has taken effective contraceptive measures within 14 days prior to screening and is willing to sign the notification until the last medication No pregnancy plan and voluntary use of effective contraceptive measures within the next 6 months; The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of this study, and understand and sign the informed consent. Exclusion Criteria: Known allergy to fluzopalil or study drug components; Patients with any factors affecting oral administration (such as previous gastric or small bowel resection, or current atrophic gastritis, chronic intestinal disease, gastrointestinal bleeding, dysphagia, gastrointestinal obstruction, or diarrhea greater than grade 1, including those who have recovered but have not recovered); Patients who underwent major surgery or gastrointestinal surgery affecting drug absorption, open biopsy, severe traumatic injury, wound unhealed or did not recover from major surgery within 1 month before the trial; Before the first administration, patients have used strong CYP3A inhibitors (such as itraconazole, telithromycin, clarithromycin, ritonavir, etc.) or medium CYP3A inhibitors (such as ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil, etc.); Patients who had used strong CYP3A inducers (e.g., phenobarbide, enzyluamide, phenytoin, rifampicin, rifambutin, rifapentine, carbamazepine, nevirapine and St. John's herb) or medium CYP3A inducers (e.g., Bosentan, efavirenz, modafinil, etc.) and did not reach 3 elimination half-lives; Pregnant or lactating women or subjects who cannot use contraception as required; Those who have special requirements on diet and cannot accept uniform diet; As judged by the researcher, there are other circumstances that are not suitable for the researcher.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab combined with Fluzoparib<br>Bevacizumab combined with Fluzoparib will be administered in patients with platinum-resistant recurrent ovarian cancer. | Drug: Bevacizumab<br>* Bevacizumab will be administered at 15mg/kg IV, every 3 weeks<br>* Other names: Antiangiogenic drugs;Drug: chemotherapy<br>* The non-platinum chemotherapy regimen will be determined by the investigator.<br>* Other names: Non-platinum chemotherapy;|
| Experimental: Bevacizumab combined with chemotherapy<br>Bevacizumab combined with non-platinum chemotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer. | Drug: Bevacizumab<br>* Bevacizumab will be administered at 15mg/kg IV, every 3 weeks<br>* Other names: Antiangiogenic drugs;Drug: chemotherapy<br>* The non-platinum chemotherapy regimen will be determined by the investigator.<br>* Other names: Non-platinum chemotherapy;|
| Experimental: Fluzoparib<br>Fluzoparib monotherapy will be administered in patients with platinum-resistant recurrent ovarian cancer. | Drug: Fluzoparib<br>* Fluzoparib will be administered orally continuously at 150mg bid until disease progression and toxicity becomes intolerable<br>* Other names: PARPi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free-Survival | The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate | It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR). | 2 years | 
| Overall Survival | Time from randomization to death from any cause (for subjects who have been lost to follow-up prior to death, the time of death is usually calculated as the time of last follow-up) | 2 years | 
| Adverse event Adverse event | It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platinum-resistant, recurrent ovarian cancer, Bevacizumab, Fluzoparib