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To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab 200mg q3w |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year disease free survival | from date of enrollment until date of first documented disease progression or from date of enrollment until date of first documented disease progression or death from any cause | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | from date of enrollment until death from any cause | 2 years |
| Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment |
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Inclusion Criteria:
Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 80 * 10^9/l Hemoglobin >= 80 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >30 ml/min 8. Signed written informed consent
Exclusion Criteria:
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Acute toxicity profiles, graded according to the NCI CTCAE version 4.0
| up to 3 months after completion of radiotherapy |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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