Treating Locally Advanced Head and Neck Malignant Tumor With Anlotinib and Chemoradiotherapy
Treating Locally Advanced Head and Neck Malignant Tumor With Anlotinib and Chemoradiotherapy
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.
Inclusion Criteria:

 -  Male or female, aged 18 to 75 years;

 -  Performance status (PS) score ≤ 1 points;

 -  The expected survival period is more than 3 months;

 -  Highly differentiated squamous cell carcinoma or non-squamous cell carcinoma of the
 head and neck diagnosed by pathology and/or cytology, including sarcoma, adenoid
 cystic carcinoma, olfactory blastoma, mucoepidermoid carcinoma, etc.; those whose
 primary tumor cannot be cured by surgery;

 -  With measurable lesions: According to the evaluation criteria for the efficacy of
 solid tumors (Response Evaluation Criteria In Solid Tumors 1.1), the patient has at
 least one measurable lesion. The measurable lesion should not have received local
 treatment such as radiotherapy (target lesion located in the previous radiotherapy
 area, if it is confirmed that significant progress has occurred , And comply with
 evaluation standard, can also be used as target lesions);

 -  No previous anti-tumor therapy, including anti-angiogenesis therapy, such as
 pazopanib, sunitinib, sorafenib, regorafenib, etc.;

 -  Sufficient liver function: total bilirubin ≤ upper limit of normal value (ULN);
 glutamic oxalacetic transaminase (AST) and glutamic-pyruvic transaminase (ALT) ≤ 2
 times upper limit of normal value (ULN); alkaline phosphatase ≤ 5 times upper limit of
 normal value (ULN);

 -  Adequate renal function: creatinine clearance rate ≥80 mL/min;

 -  Adequate blood function: absolute neutrophil count (ANC) ≥2×109/L, platelet count
 ≥100×109/L and hemoglobin ≥9g/dL;

 -  No serious heart, lung and other important organ dysfunction;

 -  Women of childbearing age must have taken reliable contraceptive measures; pregnancy
 tests (serum or urine) are negative within 7 days before enrollment, and must be
 non-lactating patients; and are willing to adopt appropriate during the test and
 within 6 months after the last treatment Methods of contraception. For men, it is
 necessary to agree to use appropriate methods of contraception or surgical
 sterilization during the trial and 8 weeks after the last dose;

 -  The subjects voluntarily joined the study and signed an informed consent form with
 good compliance and cooperated with the follow-up.

 Exclusion Criteria:

 -  Can undergo radical surgery or cannot tolerate anti-tumor treatment;

 -  Women who are pregnant or breastfeeding, have fertility but are unwilling or unable to
 take effective contraceptive measures;

 -  People with high blood pressure who cannot be well controlled by antihypertensive
 drugs (systolic blood pressure> 150 mmHg, diastolic blood pressure> 100 mmHg);

 -  Patients with clinically significant cardiovascular disease within 6 months before
 enrollment, including uncontrolled hypertension, myocardial infarction, or unstable
 angina; New York Heart Association (NYHA) congestive heart failure of grade II or
 higher, severe Of arrhythmia requiring treatment (including QT interval ≥440 ms), or
 cardiac ejection fraction <50%, peripheral vascular disease of grade II or higher;

 -  Abnormal blood coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or
 activated partial thromboplastin time (APTT) >1.5 ULN), have bleeding tendency or are
 undergoing thrombolysis or anticoagulation treatment;

 -  There was obvious hemoptysis blood 2 months before enrollment, or the daily hemoptysis
 amount was 2.5ml or more;

 -  Significant clinically significant bleeding symptoms or clear bleeding tendency, such
 as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline occult blood ++ and
 above, or suffering from vasculitis within 3 months before enrollment; Known
 hereditary or acquired bleeding and thrombotic tendency;

 -  Arterial/venous thromboembolic events within 12 months before enrollment;

 -  Have undergone major surgery within 4 weeks of enrollment or accompanied by severe,
 non-healing wounds, ulcers or fractures;

 -  There are obvious factors that affect the absorption of oral drugs;

 -  Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred 6 months
 before enrollment;

 -  Urinary routines suggest that urine protein is ≥++, and that the amount of urine
 protein in 24 hours is ≥1.0g;

 -  Serous cavity fluid accumulation with clinical symptoms and requiring symptomatic
 treatment;

 -  Active infections require antimicrobial treatment;

 -  Have a history of central nervous system diseases, including primary brain tumors,
 seizures without standard medication, any brain metastases or have cerebrovascular
 accidents (CVA, stroke), transient ischemic attack (TIA), or 6 A history of
 subarachnoid hemorrhage within the month;

 -  Participated in clinical trials of other drugs 4 weeks before enrollment;

 -  Other malignant tumors in the past or at the same time (except for malignant tumors
 that have been cured and survived for more than 5 years without cancer, such as basal
 cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid
 carcinoma, etc.);

 -  Those who have received VEGFR inhibitors, such as pazopanib, sunitinib, sorafenib,
 regorafenib, etc.;

 -  Those who are known to have a history of psychotropic substance abuse, alcoholism or
 drug use and are unable to quit or have mental disorders;

 -  The investigator judges other conditions that may affect the progress of the clinical
 study and the judgment of the research results.