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This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 | Experimental | R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 | Drug | Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of response | 24 months |
| DCR | Disease Control Rate | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi | Contact | +86-010-87788268 | syuankaipumc@126.com | |
| Qing Yang | Contact | +86-021-61052512 | yangqing@hrglobe.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tumor Hospital of the Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
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2 cohorts
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| PFS |
Progression free survival |
| 24 months |
| OS | Overall Survival | 24 months |
| AEs | Incidence and severity of adverse events | 24 months |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |