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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 in patients with pancreatic cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Radiation to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody . Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | RT to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local control | occurrence of local or regional progression | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0 | 3 months |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| C000711728 | spartalizumab |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Anti-PD-1 Antibody | Drug | Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes. |
|
Objective response rate as assessed by RECIST criteria |
| 3 months |
| Overall survival | Overall survival | 2 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |