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This study is a Prospective, Single-arm, Phase II clinical trial. The purpose of this study is to find out if taking combination therapy of Senaparib and Bevacizumab is safe and works well for people with first-line maintenance therapy in newly diagnosed advanced homologous recombination proficient ovarian cancer, and explore relevant biomarkers for evaluating the efficacy of maintenance therapy through exosome. Researchers will look at the Progression-Free Survival, Overall Survival, safety, and any side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senaparib+Bevacizumab | Experimental | Participants will receive Senaparib and Bevacizumab in combination. Senaparib qd for 2 years and Bevacizumab q3w for 15 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senaparib | Drug | 100mg qd |
| |
| Bevacizumab |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival, according to RECIST v1.1 | approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall survival, according to RECIST v1.1 | Up to 2 years |
| AEs | Adverse Events, according to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of exosome related biomarkers | Screening period, maintenance treatment for 1 month, 3 months, and disease progression will be tested separately | Up to 24 month |
Inclusion Criteria:
If the first detection value is ≤ the upper limit of normal (ULN), the subjects can be randomly divided into groups without the need for a second sampling; If the first detection value is greater than ULN, a second evaluation must be conducted at least 7 days after the first detection. If the second evaluation value of the subject is higher than the first evaluation value by ≥ 15%, the subject is not eligible for selection; 8. Within 8-12 weeks of the last chemotherapy administration, participants must be enrolled and the trial medication must be started; 9. ECOG score: 0 to 1; 10. The main organ functions are normal and meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingzhu Ju, PhD | Contact | 021-64175590 | lizfeng1231@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
Data is available per require after approved by ethics broad.
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| Drug |
7.5mg/kg q3w |
|
| From the first drug administration to within 30 days for the last treatment dose |
| ID | Term |
|---|---|
| C000729920 | senaparib |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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