Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Interventions
Group 1:Apatinib combined with concurrent chemoradiation
Group 2:Concurrent chemoradiation
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~80 years old, man or woman; 2. The pathological/cytology diagnosis of LAHNSCC, except for nasopharyngeal carcinoma, with measurable focus (helical CT scan >=10mm, conform the RECIST 1.1 standard); These include patients who cannot be surgically removed, who do not want surgery and who cannot tolerate surgery. For example, (1) Patients with LAHNSCC with initial onset of oropharynx, hypopharynx and larynx and organ retention desire; (2) Patients with LAHNSCC because of wide range of tumors that cannot be surgically removed; (3) Patients with LAHNSCC who cannot tolerate surgery due to complications with other internal diseases; 3. The patients have not received radical radiotherapy or systematic chemotherapy (except neoadjuvant therapy) or concurrent chemoradiotherapy or molecular targeted therapy in the past; 4. The patient has therapeutic indications; 5. ECOG score 0-2 and the KPS score is greater than or equal to 70; 6. The predicted survival time is greater than or equal to 3 months; 7. expected survival more than three months; 8. The main organ function, that meet the following criteria (1) HB=90 g/Lb. ANC=1.5×10^9/Lc. PLT=80×10^9/L; (2) TBIL 45 ml/min (Cockcroft-Gault formula); 9. women of childbearing age must have taken reliable contraceptive measures or 7 days before the group performed a pregnancy test (serum 1.or urine), and the result is negative, and willing to experiment and during the last eight weeks after administration of the test drugs using appropriate methods contraception. For men shall be agreed to during the trial and after the last administration of the test drugs eight weeks using appropriate methods of contraception or sterilization surgery; 10. The subjects voluntarily joined the study, and informed consent, good compliance, with the follow-up.
Exclusion criteria
Exclusion criteria: 1. pregnant or lactating; 2. Previous or co-existing malignant tumors, except cured basal cell carcinoma of the skin and orthotopic carcinoma of the cervix; 3. After suffering from high blood pressure and antihypertensive medications can not fall within the normal range (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) above the level of suffering I myocardial ischemia,myocardial infarction, arrhythmia or Class II cardiac sufficiency; 4. coagulation abnormalities (INR> 1.5 or APTT>1.5ULN + 4 seconds, or APTT>1.5 ULN), having bleeding tendency,or treated with thrombolysis and anticoagulation; 5. Patients with clear bleeding concerns; 6. Patients with positive urine protein (urine protein detection 2+ or above, or 24-hour urinary protein quantification >1.0g); 7. With a variety of factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 8. A period of 4 weeks prior to the start of taking the study drug, =CTCAE 2 pneumorrhagia or =CTCAE 3 other organs bleeding event has occurred; 9. Patients who have participated in clinical trials of other drugs in 4 weeks; 10. Investigator judgment that may affect the conduct of clinical studies and case studies determined. Patients who have a history of psychotropic drug abuse and are unable to quit or have mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression Free Survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHao jiang
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed