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Head and neck tumors include well-differentiated squamous cell carcinoma, adenocarcinoma, adenoid cystic carcinoma, small cell carcinoma, sarcoma, olfactory blastoma, and mucoepidermoid carcinoma, which are highly invasive and have a high rate of recurrence and metastasis. For tumors that cannot be radically removed at the local advanced stage, even after traditional comprehensive treatment, survival is still very low. Therefore, we need to explore new treatment methods to achieve tumor degeneration and increase the surgical resection rate or control local lesions to improve the survival rate of tumors. According to previous research reports and clinical exploration, anlotinib has evidence support for the treatment of locally advanced head and neck tumors. With a considerable effect in the early stage, we tried to initially observe the clinical treatment efficiency, toxic and side effects, progression-free survival time, overall survival time and quality of life of anlotinib in the treatment of patients with refractory head and neck carcinoma. Provide patients with a more optimal treatment plan and improve survival.
We will prospectively collect 30 patients who receive anlotinib combined with chemoradiotherapy. Data will be stored in a private database. The process of data collection will be supervised and regular data examination will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib group | Experimental | After 2 cycles of anlotinib treatment, we evaluate the therapeutic effect of tumor treatment: If it achieve downgrading and is operable, surgical treatment will be performed; if it is still inoperable and could accept radiotherapy, radiotherapy and chemotherapy will be combined with oral chemotherapy of anlotinib until the end of radiotherapy. Efficiency and side effects will be evaluated within 3 months after therapy. Finally, the survival is in follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride capsules | Drug | Using anlotinib of 2 cycles as the first-line therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Complete response rate and partial response rate: measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 by means of computed tomography (CT) or magnetic resonance imaging (MRI) at each follow-up. | Three months |
| Adverse events rate | Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0). | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen-wei Peng, Ph.D. | Contact | 008687755766 | 8576 | pzhenw@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yong Chen, M.D. | First Affiliated Hospital, Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Anlotinib treatment plus chemoradiotherapy
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| Overall survival (OS) | defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive. | Two years |