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The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 | Drug | SHR-A1811. |
| |
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity (DLT) | Up to 21 days. | |
| Recommended phase II dose (RP2D) | Up to 21 days. | |
| Objective response rate (ORR) | Every 9 weeks lasting about one year. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (DoR) | Every 9 weeks lasting about one year. | |
| Disease control rate (DCR) | Every 9 weeks lasting about one year. | |
| Progression free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuni Wang | Contact | +86-0518-81220121 | shuni.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430000 | China |
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| Drug |
Carboplatin. |
|
| Bevacizumab | Drug | Bevacizumab. |
|
| Oxaliplatin for Injection | Drug | Oxaliplatin for injection. |
|
| Paclitaxel injection | Drug | Paclitaxel injection. |
|
| Doxorubicin hydrochloride liposome injection | Drug | Doxorubicin hydrochloride liposome injetction. |
|
| Adebrelimab Injection | Drug | Adebrelimab injection. |
|
| Every 9 weeks lasting about one year. |
| Standard response rate (RR) | Every 9 weeks lasting about one year. |
| Overall survival (OS) | Approximately 3 years after the last subject enrolled. |
| Adverse events (AEs) | From the first drug administration to within 90 days after the last dose. |
| Serious adverse events (SAEs) | From the first drug administration to within 90 days after the last dose. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D007267 | Injections |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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