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The purpose of this study was to evaluate the efficacy and safety of Camrelizumab as maintenance therapy in newly diagnosed locally advanced head and neck squamous cell carcinoma subjects after chemoradiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Camrelizumab | Experimental | camrelizumab as maintenance therapy after Chemoradiation(evaluation results:PR/SD) |
|
| observation | No Intervention | observation after Chemoradiation | |
| Exploration:Camrelizumab | Experimental | camrelizumab for maintenance after chemoradiation( evaluation results:CR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| median progression-free survival(in accordance with RECIST1.1) | mPFS is the median time from the date of randomization to the date of first record of disease progression or death. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year progression-free survival rate | 1 year from the the date of randomization | |
| overall survival | OS is the time from randomization to death due to any cause. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival in exploration group | EFS is the time from the date of randomization to any event | Up to 3 years |
Inclusion Criteria:
Normal bone marrow reserve function: WBC≥3.0×10^9/ L, NEUT≥1.5×10^9/ L, PLT≥80×10^9/ L, Hb≥90g/L Normal renal function or SCr≤1.5 times normal upper limit (ULN) or Ccr≥50 ml/min ; Normal liver function or TBIL≤1.5 times the upper limit of normal value (ULN); AST or ALT level 2.5 times the upper limit of normal value (ULN);
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junlin Yi | Contact | 13661217998 | yijunlin1969@163.com | |
| Ye Zhang | Contact | 010-87787625 | drzye1983@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junlin Yi | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital, Chineses Academy of Medical Sciences | Beijing | 100021 | China |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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| objective response rate | Up to 3 years |
| disease control rate | Up to 3 years |
| time to progression | Up to 3 years |
| progression-free survival(in accordance with irRECIST1.1) | Up to 3 years |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |