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This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab Combined With Fuzuloparib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | 20mg/kg,D1,q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | ORR is determined using RECIST v1.1, Defined as the optimal overall response (CR or PR) at the time point assessed from enrollment to the end of neoadjuvant therapy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | Defined as the time from the enrollment to death from any cause | 3 years |
| Progression free survival(PFS) | It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Sun, Doctor | Contact | 15959028989 | garyhanyu@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Sun, Doctor | Fujian Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fujian | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010049 | Ovarian Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000291 | Adnexal Diseases |
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| Fuzuloparib |
| Drug |
100 mg bid |
|
| 3 years |
| Disease Control Rate(DCR) | DCR is determined using RECIST v1.1, Defined as the rate of disease control (CR or PR or SD) from enrollment to the end of neoadjuvant therapy. | 3 years |
| 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 |