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The goal of this clinical trial is to test in describe participant population. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunotherapy combined with chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab, Paclitaxel (albumin-bound type), Cisplatin, 5-FU | Drug | evaluate the efficacy and safety of immunotherapy combined with chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of pathological examination | Changes in pathologic examination before treatment and after 3-cycle induction therapy were evaluated to derive the number and proportion of patients with pathological complete remission | Change from Baseline pathologic examination at the end of Cycle 3 (each cycle is 21 days) |
| Change of tumor size | imaging (MRI or CT) assessment according to RECIST v1.1 was performed and documented during follow-up as required | Change from baseline tumor size at the end of Cycle 3 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Security assessment | according to the NCI-CTCAE 4.0 adverse reaction evaluation criteria | At the end of Cycle 3 (each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Yan | Contact | +86 15805182426 | firefreebird@163.com | |
| Kongcheng Wang | Contact | +86 13814165197 | wangxxbz@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Drum Tower Hospital, Nanjing University School of Medicine | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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