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For resectable squamous cell carcinoma of the head and neck , novel therapeutic approaches are still needed to improve outcomes. Neoadjuvant immunochemotherapy is considered as a potentially effective strategy. The purpose of this study is to evaluate the safety and efficacy of neoadjuvant of tislelizumab combined with platinum doublet for resectable locally-advanced head and neck squamous-cell carcinoma .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therapy of tislelizumab with chemotherapy | Experimental | Neoadjuvant Tislelizumab plus double platinum based chemotherapy for 2 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab: 200mg,administered via Intravenous (IV) injection, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (PCR) | From neoadjuvant therapy to surgical resection, up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (MPR) | In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%. | From neoadjuvant therapy to surgical resection, up to 6 weeks |
| 3-year Disease-free survival (DFS) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Lu, professor | Contact | 027-83662691 | luxiangent@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Guangyuan Hu, professor | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
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|
| Nab-paclitaxel | Drug | 260mg/m^2, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 2 cycles |
|
| Carboplatin | Drug | AUC 5 mg/mL/min by IV infusion once every 3 weeks,day 1 of each 21-day cycle,neoadjuvant therapy : 2 cycles |
|
Time from randomization to disease recurrence or death of any cause |
| 3-years after surgery |
| 3-year overall survival(OS)rate | The proportion of all study cases in which no death from any cause occurred within 3 years after surgery | 3-years after surgery |
| 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 |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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