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This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1: SHR-A1921 | Experimental |
| |
| Treatment group 2: Investigator's choice of chemotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1921 | Drug | SHR-A1921 dose 1 |
| |
| Doxorubicin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Screening up to study completion, an average of 1 year | |
| Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuni Wang | Contact | +86 021-61053363 | shuni.wang@hengrui.com | |
| Di Zong | Contact | +86 021-61053363 | di.zong@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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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 |
|---|---|
| D004317 | Doxorubicin |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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To evaluate the efficacy and safety of SHR-A1921 compared with investigator-chosen chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.
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| Drug |
Doxorubicin dose 2 |
|
| Paclitaxel | Drug | Paclitaxel dose 3 |
|
| Topotecan | Drug | Topotecan dose 4 |
|
| Duration of Response (DoR), assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria | Screening up to study completion, an average of 1 year |
| CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria | Screening up to study completion, an average of 1 year |
| Adverse Events | Screening up to study completion, an average of 1 year |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| 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 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |