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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Using anlotinib of 2 cycles as the first-line therapy.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGObjective 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.
Time frame: Three months
Adverse events rate
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
Time frame: Three months
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.
Time frame: Two years
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.
Time frame: Two years
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