head and neck squamous cell carcinoma
Conditions
Interventions
experimental group A:Melbine with chemoradiotherapy
control group A:Chemoradiotherapy
experimental group B:Melbine with chemoradiotherapy
control group B:Chemoradiotherapy
Sponsors
Bethune International Peace Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients aged >= 18 years, male and female. 2) Pathological confirmed of head and neck squamous cell carcinoma; 3) TNM stage T3-4N0M0, TxN1-2M0, TxNxM1a (cervical lymph node metastasis); 4) Patients with expected survival >= 6 months; 5) KPS >= 70; 6) Hemoglobin >= 100g/L, platelet >=100 x 10^9/L, neutrophil >= 1.5x10^9/L;serum creatinine SCR 0.8L; 8) Women of childbearing age need to take appropriate contraceptive measures and should not breastfeed 3 months after screening and stopping the research and treatment. Prior to the start of administration, the pregnancy test was negative, or one of the following criteria was met to demonstrate that there was no risk of pregnancy: a. Postmenopause is defined as amenorrhea in patients over 50 years of age and at least 12 months after cessation of all hormone replacement therapy. b. Women younger than 50 years old can also be considered as postmenopausal women if they have amenorrhea for 12 months or more after stopping all exogenous hormone treatment, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference values. c. Subjects who had undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except for bilateral tubal ligation. 9) Barrier contraception (i.e. condom) should be used in male patients from screening to 3 months after discontinuation of study treatment. 10) Patients must sign informed consent form.
Exclusion criteria
Exclusion criteria: 1) There are contraindications to radiotherapy and chemotherapy (such as active infection, symptomatic heart disease within 6 months after myocardial infarction, including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy). 2) The general condition of the patient is poor, and the KPS score is less than 70. 3) Patients who have previously treated with surgery and/or Chemoradiotherapy; 4) Patients who complicate with other malignant tumors; 5) Patients who relapse after surgery; 6) Non-newly diagnosed patients have previous treatmentany previous or current treatment for invasive head and neck cancer of any kind (including, but not limited to, previous tyrosine kinase inhibitors, previous neoadjuvant therapy, previous surgical resection, or use of any investigational agent) 7) Have received any of the following treatments: a. Have used any EGFR tyrosine kinase inhibitor in the past; b. Any previous chemotherapy for head and neck cancer c. Any previous radiotherapy for head and neck cancer d. The patient had undergone major surgery within weeks before the first administration of the study drug; 8) Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug. 9) Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy. 10) Weight loss of more than 10% during the previous month; 11) Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;non-compensated liver cirrhosis or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial OR which would jeopardize compliance with the protocol such as active infection. Screening for chronic conditions is not required. 12) Refractory nausea, vomiting, or chronic gastrointestinal disease, inability to swallow research drugs, or extensive bowel resection may interfere with adequate absorption of DHA. 13) Any of the following cardiac criteria: a.Mean resting corrected QT interval (QTc) > 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF). b.Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 ms). c.Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. d.Left ventricular ejection fraction (LVEF) 2.5 x upper limit of normal (ULN) if no demonstrable liver metastases or > 5 x ULN in the presence of liver metastases. e.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DoR;Safety; | — |
Countries
China
Contacts
Public ContactShan Shan
Bethune International Peace Hospital
Outcome results
None listed