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| Name | Class |
|---|---|
| Nanjing Geneseeq Technology Inc. | INDUSTRY |
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| biomarker study and treatment study | Experimental | All enrolled patients undergo biomarker study and treatment study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination therapy | Drug | SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment. | up to approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment. | up to approximately 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongying Liao, Professor | Contact | +86 13928845885 | hylmed1996@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Overall Survival (OS) | Defined as the time from the enrollment to death from any cause | up to approximately 1 year |
| Disease Control Rate (DCR) | The proportion of patients who have achieved complete responseļ¼ partial response and Stable disease assessed by investigators according to Recist v 1.1. | up to approximately 1 year |
| Adverse events (AEs) | All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03 | up to approximately 1 year |