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This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-6390 | Experimental | SHR-6390 |
|
| SHR-6390 combined with Camrelizumab (SHR-1210) | Experimental | SHR-6390 combined with Camrelizumab (SHR-1210) |
|
| Camrelizumab (SHR-1210) combined with SHR-1020 | Experimental | Camrelizumab (SHR-1210) combined with SHR-1020 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-6390 | Drug | SHR-6390 |
| |
| SHR-6390 + Camrelizumab (SHR-1210) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective Response Rate is defined as the percentage of patients whose tumors have a complete or partial response to treatment among eligible and treated patients. Objective response rate is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1 criteria. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free-Survival | Progression-Free-Survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. | Up to 1 year |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
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| Drug |
SHR-6390 combined with Camrelizumab (SHR-1210) |
|
| Camrelizumab (SHR-1210) + SHR-1020 | Drug | Camrelizumab (SHR-1210) combined with SHR-1020 |
|
Overall survival is defined as time from treatment start date to date of death from any cause. Patients alive at the time of analysis are censored at last contact date.
| Up to 1 year |
| Subject safety | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | Up to 1 year |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C584390 | famitinib |
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