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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Radiation to 60 Gy, 5 x per week, for 6 weeks. Radiation begun the day after the first dose of SHR-1210. SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Drug | RT to 60 Gy, 5 x per week,for 6 weeks. Radiation begun the day after the first dose of SHR-1210 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1. | 4-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events | Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion. | year 0 - year 1 |
| Local-regional free survival (LRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Cancer Hospital | Hangzhou | Zhejiang | 310002 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D004935 | Esophageal Diseases |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| SHR-1210 | Drug | SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes. |
|
LRFS was calculated from the date of treatment initiation to the date of documented failure. |
| year 0 - year 3 |
| Overall survival | OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death. | year 0 - year 3 |
| Health-related quality of life (HRQoL) | HRQoL measured by standardized EORTC questionaires (EORTC QLQ-C30) | From baseline to one year after RT. |
| Health-related quality of life (HRQoL) | HRQoL measured by standardized EORTC questionaires (EORTC QLQ-OES18) | From baseline to one year after RT. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |