Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
neoadjuvant chemotherapy:Anlotinib: 12mg/d, Q3W, subjects take Anlotinib orally every day for two weeks, stop for one week, and stop 2 weeks before surgery.
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The volunteers who joined the study and signed the informed consent, had good compliance and follow-up cooperation. 2.Men and women aged 18-70. 3.Patients with locally advanced oral cancer confirmed by pathology (III-IVb), including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer. 4.Determined by the investigator to be operable or potentially operable,patients primary tumor were not treated with surgery or radiatio. 5.At least one measurable lesion (RECIST 1.1). 6.ECOG score: 0-1; The expected survival time was more than 6 months. 7.No previous systemic antitumor therapy. 8.The major organs are functioning normally, whitch meet the following criteria. 9.The standard of blood routine examination should be met (no blood transfusion and blood products, no G-CSF or other hematopoietic stimulating factors for correction within 14 days). a.HB=90g/L b.ANC=1.5×109/L; c.PLT=80×109/L; 10.Biochemical tests must meet the following criteria a.TBIL 60 ml/min(Cockcroft-Gault formula); 11.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = the lower limit of normal (50%). 12.Women of childbearing age who were not sterilized had a negative pregnancy test (serum or urine) within 7 days before study enrollment and were willing to use an appropriate method of contraception during the trial and up to 8 weeks after the last administration of the trial drug. For men, consent was required to use an appropriate method of contraception during the trial and up to 8 weeks after the last administration of the trial drug or had been surgically sterilized.
Exclusion criteria
Exclusion criteria: 1.The people who has been treated with antiangiogenic agents (e.g., Sunitinib, Sorafenib, Regorafenib, Bevacizumab, Smatinib, Spatinib, etc.) 2.The patients with deep ulcers, with necrotic lesions or who have been assessed by investigators to be at risk for bleeding adjacent to important blood vessels. 3.Clinically significant bleeding symptoms or definite bleeding tendency occurred within 3 months before enrollment. 4.Patients were enrolled in another clinical study or had been treated less than 4 weeks since the end of the previous clinical study. 5. The patients had other active malignant tumors within 5 years at the presence or current presence. Exceptions were patients with basal cell carcinoma of the skin, superficial bladder cancer, or cervical cancer in situ who had undergone potentially curative therapy and had no disease recurrence within 5 years of treatment initiation. 6.Patients who have received external radiation therapy in 3 months or unplanned systemic antitumor therapy, including cytotoxic therapy, signal transduction inhibitors (or had used mitomycin C within 6 weeks before receiving trial drug therapy). Chinese medicine treatment should not be allowed at the same time. 7.Uncontrolled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg, despite optimal medical therapy). 8.Patients with adverse effects (except alopecia) caused by any previous treatment that did not recover to NCI-CTCAE grade 5.0=2. 9.The patients have abnormal coagulation (international normalized ratio of prothrombin time (INR) >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or being treated with thrombolytic or anticoagulant therapy; Note: Low-dose heparin (adult dose: 0.6 to 12,000 U per day) or low-dose aspirin (daily dose: 100 mg or less) is allowed for preventive purposes under the premise of INR=1.5. 10.Renal insufficiency: urine routine indicates urinary protein = ++, or confirmed 24-hour urinary protein =1.0g. 11.Had undergone major surgery 28 days before enrollment. A wound or fracture that has not healed for a long time. 12.Patients with pleural effusion or pneumothorax of grade 3 or above according to NCI-CTCAE 5.0 classification criteria. 13.Severe acute or chronic infections requiring systemic treatment. 14.Severe cardiovascular disease: higher grade ? myocardial ischemia or infarction, uncontrolled arrhythmias (including QTc interval =450 ms in men and =470 ms in women). According to NYHA criteria, grade ?? cardiac insufficiency, or left ventricular ejection fraction (LVEF) 10mmol/ml). 17.There are obvious factors that affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction. 18.Patients with clinically significant bleeding symptoms or clear bleeding tendency in 3 months before enrollment, such as respiratory tract bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or higher, or angiitis. Patients who had perivascular invasion on imaging or who were judged by the investigator to have a high likelihood of major vascular invasion causing fatal bleeding during the follow-up study. 19.Arterial/venous thrombotic events occurred in 12 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR, disease control rate;R0 resection rate; | — |
Countries
China
Contacts
Public ContactWang anxun
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed