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This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 Injection | Drug | SHR-A1811 for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) assessed by Independent Review Committee (IRC) | Up to 2 years. | |
| Overall survival (OS) assessed by investigators | Up to 2 years. | |
| Progression free survival (PFS) assessed by Independent Review Committee (IRC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Na An | Contact | +86-0518-82342973 | na.an@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350011 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
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| Up to 2 years. |
| Progression free survival (PFS) assessed by investigators | Up to 2 years. |
| Duration of response (DoR) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Duration of response (DoR) assessed by investigators | Up to 2 years. |
| Disease control rate (DCR) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Disease control rate (DCR) assessed by investigators | Up to 2 years. |
| Objective response rate (ORR) assessed by investigators | Up to 2 years. |
| Adverse events (AEs) | Up to 2 years. |
| Serious adverse events (SAEs) | Up to 2 years. |
| Shandong University Qilu Hospital | Recruiting | Jinan | Shandong | 250063 | China |
|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |