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The purpose of this study is to assess the safety and efficacy of AK104 plus concurrent chemoradiation therapy in unresectable locally advanced esophageal squamous cell carcinoma
AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles. Assess disease efficiency( objective response rate; disease control rate; duration of overall response; time to resolve) and safety( adverse event).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 plus concurrent chemoradiation therapy | Experimental | AK104 10mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 10 mg/kg plus TC regimen(paclitaxel liposome 135mg/m2, carboplatin AUC=5) is combined with radiotherapy(50Gy/25F) for 2 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | AK104 plus TC regimen(paclitaxel liposome , carboplatin), once every 3 weeks (Q3W), induction treatment for 2 cycles; Subsequently, AK104 plus TC regimen is combined with radiotherapy for 2 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 24 months |
| DCR | disease control rate | 24 months |
| DoR | duration of overall response | 24 months |
| TTR | time to resolve | 24 months |
| AE | adverse event | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | 24 months |
| OS | overall survival | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| 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 |