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To evaluate the efficacy and safety of adebrelimab combined with TP chemotherapy regimen as neoadjuvant therapy for locally advanced hypopharyngeal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Adebrelimab combined with albumin, paclitaxel and cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab+Albumin paclitaxel +Cisplatin | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (pCR) | Pathological examination of the resected tissue samples did not reveal any residual tumor cells. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) | Major pathological response (MPR) is defined as the presence of active tumor tissue in surgical specimens ≤10% at the time of tumor resection. | six months |
| Surgical R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangang Wu | Contact | 15960208092 | wusg@xmu.edu.xn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
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The proportion of the resection margin without residual cancer cells
| Six months |
| Laryngeal function retention rate | It refers to the proportion of subjects whose laryngeal functions (including vocalization, breathing and swallowing functions) are successfully preserved during the treatment process through methods such as surgery, radiotherapy, chemotherapy or comprehensive treatment. | six months |
| The intensity of the surgery has decreased | The researchers determined whether the surgical intensity had decreased based on the subjects' conditions. | six months |
| Objective response rate (ORR) | It refers to the proportion of all subjects whose best overall response (BOR) was rated as complete response (CR) or partial response (PR) according to the RECIST 1.1 standard. | one year |
| Disease Control rate (DCR) | It refers to the proportion of all subjects whose overall response rate (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to the RECIST 1.1 standard. | One year |
| Recurrence-free survival time (RFS) | It refers to the period from the date of successful surgery to recurrence or death. | Two years |
| Overall survival (OS) | Defined as the period from the date of the first administration to the death of the subject for various reasons. | Two years |
| Adverse event(AE) | The incidence and severity of adverse events (AE) evaluated according to CTCAE 5.0 | Two years |
| ID | Term |
|---|---|
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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