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The study will be a Prospective, Single-arm, Phase â…¡ 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.
Due to the lack of effective predictive molecular markers in the maintenance treatment phase, it is difficult to assess the effectiveness of maintenance treatment. This project plans to collect blood and urine from subjects before maintenance treatment, during relapse, and for follow-up molecular marker exploration research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuzuloparib Combination with Bevacizumab | Experimental | Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg,d1,Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuzuloparib Combination with Bevacizumab | Drug | For the first 6 patients, if DLT≤33.3%, Fuzuloparib 150mg/bid will be used for follow-up research; if DLT>33.3%, Fuzuloparib will be used for follow-up research at 100mg/bid; Bevacizumab 7.5mg/kg, d1, Q3W. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | according to RECIST v1.1 | approximately 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | according to RECIST v1.1 | Up to approximately 1.5 years |
| Adverse Events (AEs) | 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 |
|---|---|---|
| Exploration of molecular markers | Through the analysis of serum and urine proteomics and metabolomics, predictive PFS markers were screened,for example,CA 125, ctDNA | Up to approximately 1.5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhong Zheng, Ph.D | Contact | 02164175590 | 82900 | alizheng@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhong Zheng, Ph.D | Department of Gynecologic Oncology, Fudan University Shanghai Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Cente | Shanghai | Shanghai Municipality | 200032 | China |
Data is available per require after approved by ethics broad
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| From the first drug administration to within 30 days for the last treatment dose] |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |